Diclofenac Delayed Release Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Carlsbad Technology, Inc. (2015-09-04)
Oldest Current Product
1995-09-28
License(s)
ANDA
RxNORM
DELAYED RELEASE ORAL TABLET\DICLOFENAC
FDAOB
ORAL\TABLET, DELAYED RELEASE\DICLOFENAC SODIUM
SPL Active
ORAL\TABLET, DELAYED RELEASE\DICLOFENAC SODIUM
SPL Moiety
ORAL\TABLET, DELAYED RELEASE\DICLOFENAC

product(s) by strength(s)

diclofenac sodium 25 mg delayed release oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007811785ANDASandoz Inc1995-09-28DICLOFENAC SODIUMORALTABLET, DELAYED RELEASEANDA0743767a7ee8e2-5137-4abf-9d75-5db51a69b88b
2165710203ANDAPack Pharmaceuticals Llc2010-12-31DICLOFENAC SODIUMORALTABLET, DELAYED RELEASEANDA0900663330ea92-fc9d-4541-b378-be399b0995d3
3614420101ANDACarlsbad Technology, Inc.1998-11-13DICLOFENAC SODIUMORALTABLET, DELAYED RELEASEANDA07518540879600-ba6c-43a8-aa5d-d0d41503d593
4680010202ANDABluepoint Laboratories2014-02-24DICLOFENAC SODIUMORALTABLET, DELAYED RELEASEANDA074376cbdc93dd-860a-4bf7-b86f-5c9c9e2e553b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548683999ANDAPhysicians Total Care, Inc.2004-05-21DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE007811785ANDA074376bd27460e-46ff-4450-a4f2-a41420c1f93d
2581180201ANDAClinical Solutions Wholesale2010-12-31DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE165710201ANDA0900665aaa3f1d-9792-4ce1-8895-9d5f3e871a2a
3681512481ANDACarilion Materials Management1995-09-28DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE007811785ANDA074376a65aa738-8ce2-4276-8e54-5ecf4f461d3a

diclofenac sodium 50 mg delayed release oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002282550ANDAActavis Elizabeth Llc1996-03-26DICLOFENAC SODIUMORALTABLET, DELAYED RELEASEANDA074514a57b897e-0cbe-4ac3-969f-b00357a0cfa8
2003786280ANDAMylan Pharmaceuticals Inc.2010-05-18DICLOFENAC SODIUMORALTABLET, DELAYED RELEASEANDA0752814b0d7319-a587-4648-bded-5b35b8efa1cb
3007811787ANDASandoz Inc1995-09-28DICLOFENAC SODIUMORALTABLET, DELAYED RELEASEANDA0743767a7ee8e2-5137-4abf-9d75-5db51a69b88b
4165710202ANDAPack Pharmaceuticals Llc2010-12-31DICLOFENAC SODIUMORALTABLET, DELAYED RELEASEANDA0900663330ea92-fc9d-4541-b378-be399b0995d3
5614420102ANDACarlsbad Technology, Inc.1998-11-13DICLOFENAC SODIUMORALTABLET, DELAYED RELEASEANDA07518540879600-ba6c-43a8-aa5d-d0d41503d593
6680010201ANDABluepoint Laboratories2014-02-24DICLOFENAC SODIUMORALTABLET, DELAYED RELEASEANDA074376cbdc93dd-860a-4bf7-b86f-5c9c9e2e553b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006154506ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1996-03-26DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE002282550ANDA07451470c96b78-3702-4216-819f-1071770494bf
2105440114ANDABlenheim Pharmacal, Inc.2013-03-28DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE002282550ANDA07451417151304-01b7-1bed-e054-00144ff8d46c
3105440188ANDABlenheim Pharmacal, Inc.2013-11-30DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE614420102ANDA075185cc715a60-32e0-4d31-a1df-2a591a56d4e5
4105440923ANDABlenheim Pharmacal, Inc.2015-05-18DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE002282550ANDA07451496edaa7d-8c1c-46d1-8e80-b51072e55ed9
5105440934ANDABlenheim Pharmacal, Inc.2015-07-15DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE165710202ANDA0900661ea0a3ac-88ab-48c1-e054-00144ff8d46c
6165900074ANDAStat Rx Usa Llc1995-09-28DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE007811787ANDA074376d207da6e-d074-4dab-95f1-265b1df41aea
7216950038ANDARebel Distributors Corp1996-03-26DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE002282550ANDA0745146b7fb6b7-2f58-4cb6-b48f-e9b4cf292365
8353560725ANDALake Erie Medical Dba Quality Care Products Llc2010-12-31DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE165710202ANDA090066bfa8cb40-3528-4d41-ae77-444e521e30c0
9422540059ANDARebel Distributors Corp2012-04-10DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE005910338ANDA07518505a94f49-3f12-462c-9180-ae75719d3441
10422910230ANDAAvkare, Inc.1998-11-13DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE614420102ANDA07518519b4ff5c-adb7-a0d0-7ef2-4ae05047fd94
11425490589ANDAStat Rx Usa Llc2010-03-05DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE003786280ANDA0752812d92077c-75d2-4b34-8704-71660f77a63b
12430630467ANDAPd-Rx Pharmaceuticals, Inc.1996-03-26DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE002282550ANDA074514663a3dbc-a631-4046-8852-ec619c41c81d
13430630566ANDAPd-Rx Pharmaceuticals, Inc.1996-03-26DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE002282550ANDA074514381a14e5-65d3-487c-b0d2-b483b0d2824d
14433530784ANDAAphena Pharma Solutions - Tennessee, Llc1998-11-13DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE422910230ANDA0751850c4281ab-1cd8-4e45-904c-9b9f5940c3bb
15493490937ANDARemedyrepack Inc.2012-03-27DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE002282550ANDA0745145beea615-1892-41fb-8c39-3f70aa6ab63d
16499990233ANDALake Erie Medical Dba Quality Care Products Llc2012-04-10DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE005910338ANDA0751858a33def9-169d-4370-ba72-9d7a4117530e
17504361182ANDAUnit Dose Services1995-09-28DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE007811787ANDA074376807a0f13-93e5-4388-b3e9-5edc2a319640
18510790466ANDAMylan Institutional Inc.2010-06-04DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE003786280ANDA075281e8527a76-4efc-4ead-a11d-87252693fa36
19516550308ANDANorthwind Pharmaceuticals, Llc2015-01-16DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE002282550ANDA074514bfcd5d3b-30f8-4483-89e2-c67b41b22811
20548683659ANDAPhysicians Total Care, Inc.1995-11-16DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE007811787ANDA074376bd27460e-46ff-4450-a4f2-a41420c1f93d
21552890166ANDAPd-Rx Pharmaceuticals, Inc.1995-09-28DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE007811787ANDA07437636ce096d-625f-4907-bfaa-49ac04dc7df1
22581180212ANDAClinical Solutions Wholesale2010-12-31DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE165710202ANDA0900665aaa3f1d-9792-4ce1-8895-9d5f3e871a2a
23604290057ANDAGolden State Medical Supply, Inc.2014-08-12DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE614420102ANDA0751857a7e69c1-6eea-4f27-b2ed-3e5fb176fdae
24607600788ANDASt Marys Medical Park Pharmacy2014-04-21DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE002282550ANDA074514217f6c23-9a2e-4647-b4d2-ea9f9eb413c0
25619190074ANDADirect Rx2014-01-01DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE614420102ANDA0751852ae3c1e2-f053-4efb-9597-eeac4998d23f
26631870522ANDAProficient Rx Lp1996-03-26DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE002282550ANDA074514f5b4e308-c156-4865-95ee-1a8e267535ba
27663360238ANDADispensing Solutions, Inc.1996-03-26DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE002282550ANDA0745141877c2fb-39f7-45e3-b7f0-eb834ee273e4
28675440840ANDAAphena Pharma Solutions - Tennessee, Inc.1996-03-26DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE002282550ANDA0745140055edbf-f1f6-4b50-8e41-202c5a2a7883
29687889175ANDAPreferred Pharmaceuticals, Inc.2010-12-31DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE165710202ANDA090066e780534f-5b33-42f8-ae35-ccf8ee652035
30687889185ANDAPreferred Pharmaceuticals, Inc.2010-05-18DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE003786280ANDA075281f32c0225-fd21-468a-90f5-6083071e80fb

diclofenac sodium 75 mg delayed release oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002282551ANDAActavis Elizabeth Llc1996-03-26DICLOFENAC SODIUMORALTABLET, DELAYED RELEASEANDA074514a57b897e-0cbe-4ac3-969f-b00357a0cfa8
2003786281ANDAMylan Pharmaceuticals Inc.2010-05-18DICLOFENAC SODIUMORALTABLET, DELAYED RELEASEANDA0752814b0d7319-a587-4648-bded-5b35b8efa1cb
3007811789ANDASandoz Inc1995-11-30DICLOFENAC SODIUMORALTABLET, DELAYED RELEASEANDA0743947a7ee8e2-5137-4abf-9d75-5db51a69b88b
4165710201ANDAPack Pharmaceuticals Llc2008-08-19DICLOFENAC SODIUMORALTABLET, DELAYED RELEASEANDA0778633330ea92-fc9d-4541-b378-be399b0995d3, df63e944-bfb7-453d-bbd8-63f545826784
5614420103ANDACarlsbad Technology, Inc.1998-11-13DICLOFENAC SODIUMORALTABLET, DELAYED RELEASEANDA07518540879600-ba6c-43a8-aa5d-d0d41503d593
6680010200ANDABluepoint Laboratories2014-02-24DICLOFENAC SODIUMORALTABLET, DELAYED RELEASEANDA074394cbdc93dd-860a-4bf7-b86f-5c9c9e2e553b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006154507ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1996-03-26DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE002282551ANDA07451470c96b78-3702-4216-819f-1071770494bf
2105440189ANDABlenheim Pharmacal, Inc.2013-09-30DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE614420103ANDA075185770b5db0-3565-409d-a274-caa132fb8d89
3105440921ANDABlenheim Pharmacal, Inc.2015-05-27DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE002282551ANDA07451417151304-01b7-1bed-e054-00144ff8d46c
4105440933ANDABlenheim Pharmacal, Inc.2008-08-19DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE165710201ANDA0778631b52cd67-bbc7-251f-e054-00144ff8d46c
5216950039ANDARebel Distributors Corp1996-03-26DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE002282551ANDA0745146b7fb6b7-2f58-4cb6-b48f-e9b4cf292365
6353560714ANDALake Erie Medical Dba Quality Care Products Llc2008-08-19DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE165710201ANDA077863bfa8cb40-3528-4d41-ae77-444e521e30c0
7422540036ANDARebel Distributors Corp2008-08-19DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE165710201ANDA0778631b291d0a-1350-4637-bab3-f0bf43ab2a13
8422910231ANDAAvkare, Inc.1998-11-13DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE614420103ANDA07518519b4ff5c-adb7-a0d0-7ef2-4ae05047fd94
9425490510ANDAStat Rx Usa Llc2010-03-05DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE003786281ANDA0752812d92077c-75d2-4b34-8704-71660f77a63b
10493490276ANDARemedyrepack Inc.2011-06-02DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE007811789ANDA074394f674ad5c-b022-463a-af41-05bb03ee171b
11493490888ANDARemedyrepack Inc.2012-03-02DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE165710201ANDA0778636fcb75a2-095d-424b-b9ac-f843a8e1d9b1
12499990089ANDALake Erie Medical Dba Quality Care Products Llc2012-04-10DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE005910339ANDA0751858a33def9-169d-4370-ba72-9d7a4117530e
13504366924ANDAUnit Dose Services2008-08-19DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE165710201ANDA077863f0e00d55-02b7-4642-a60e-6a5841932ca5
14510790224ANDAMylan Institutional Inc.2010-06-04DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE003786281ANDA075281e8527a76-4efc-4ead-a11d-87252693fa36
15521250297ANDARemedyrepack Inc.2013-06-04DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE614420103ANDA07518529d4e5e9-cfe7-44d4-9bd6-e4d376f65972
16521250505ANDARemedyrepack Inc.2013-06-24, 2013-12-04DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE614420103ANDA0751851bc60f67-86a4-4047-8a3b-ec1d16ebabca, c1cdbca7-8ea7-42c4-a8b5-c04ce0aadd09
17529590423ANDAH.J. Harkins Company, Inc.2008-08-19DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE165710201ANDA077863e424b30d-8f40-48b7-bb99-415f92d84ed0
18548683837ANDAPhysicians Total Care, Inc.1997-02-10DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE007811789ANDA074394bd27460e-46ff-4450-a4f2-a41420c1f93d
19551543434ANDACardinal Health1995-11-30DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE007811789ANDA074394716bf76f-ae98-498d-8960-0b35aa90c92b
20552890150ANDAPd-Rx Pharmaceuticals, Inc.1996-03-26DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE002282551ANDA07451487d5a720-f154-4c4b-b2d4-0ae58455dda0
21604290058ANDAGolden State Medical Supply, Inc.2014-08-12DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE614420103ANDA0751857a7e69c1-6eea-4f27-b2ed-3e5fb176fdae
22619190075ANDADirect Rx2014-01-01DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE614420103ANDA0751852ae3c1e2-f053-4efb-9597-eeac4998d23f
23631870012ANDAProficient Rx Lp2008-08-19DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE165710201ANDA0778631eb7a7bb-c524-4168-8ade-4601dc11533b
24631870222ANDAProficient Rx Lp1998-11-13DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE614420103ANDA07518573a46413-ecbc-4453-814d-bec955b375d2
25636291535ANDABryant Ranch Prepack1996-03-26DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE002282551ANDA0745142840012a-3466-4a86-a316-d555f421e23b
26637390800ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2011-07-01DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE002282551ANDA07451424845e58-5bfe-4a74-beec-696a564fb68c
27663360463ANDADispensing Solutions, Inc.2008-08-19DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE165710201ANDA077863f940aa00-2a88-44ce-b36f-fd51552b2c2b
28675440899ANDAAphena Pharma Solutions - Tennessee, Inc.1996-03-26DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE002282551ANDA0745140055edbf-f1f6-4b50-8e41-202c5a2a7883
29680840333ANDAAmerican Health Packaging2009-04-02DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE165710201ANDA077863d44134d1-2ca9-4249-872c-65a7186870c8
30683870260ANDAKeltman Pharmaceuticals Inc.DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE165710201ANDA077863eff16712-d4c4-4e7b-bf38-c467de1095f4
31687889231ANDAPreferred Pharmaceuticals, Inc.2008-08-19DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE165710203ANDA090066e780534f-5b33-42f8-ae35-ccf8ee652035
32687889806ANDAPreferred Pharmaceuticals, Inc.2015-08-31DICLOFENAC SODIUMORALTABLET, DELAYED RELEASE614420103ANDA075185c933eaad-ba53-4130-90db-a66f89dfc29f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074376DICLOFENAC SODIUMSANDOZ INC1995-09-28ANDA074376_001, ANDA074376_002
2ANDA074390DICLOFENAC SODIUMTrueTEVA PHARMACEUTICALS USA INC1996-08-15ANDA074390_001
3ANDA074391DICLOFENAC SODIUMTrueROXANE LABORATORIES INC1995-06-29ANDA074391_001, ANDA074391_002, ANDA074391_003
4ANDA074394DICLOFENAC SODIUMSANDOZ INC1995-11-30ANDA074394_001
5ANDA074432DICLOFENAC SODIUMTruePLIVA INC1999-07-29ANDA074432_002, ANDA074432_003
6ANDA074459DICLOFENAC SODIUMTrueTEVA PHARMACEUTICALS USA1997-06-25ANDA074459_001, ANDA074459_002, ANDA074459_003
7ANDA074514DICLOFENAC SODIUMACTAVIS ELIZABETH LLC1996-03-26ANDA074514_001, ANDA074514_002
8ANDA074723DICLOFENAC SODIUMTrueTEVA PHARMACEUTICALS USA INC1999-03-30ANDA074723_001
9ANDA074986DICLOFENAC SODIUMTrueNOSTRUM LABORATORIES INC1999-02-26ANDA074986_001, ANDA074986_002
10ANDA075185DICLOFENAC SODIUMCARLSBAD TECHNOLOGY INC1998-11-13ANDA075185_001, ANDA075185_002, ANDA075185_003
11ANDA075281DICLOFENAC SODIUMMYLAN PHARMACEUTICALS INC2002-02-12ANDA075281_002, ANDA075281_003
12ANDA077863DICLOFENAC SODIUMUNIQUE PHARMACEUTICAL LABORATORIES2007-06-08ANDA077863_003
13ANDA090066DICLOFENAC SODIUMUNIQUE PHARMACEUTICAL LABORATORIES2010-12-01ANDA090066_001, ANDA090066_002
14NDA019201VOLTARENTrueNOVARTIS PHARMACEUTICALS CORP1988-07-28NDA019201_001, NDA019201_002, NDA019201_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074376_001RXDICLOFENAC SODIUM (25MG)ORALTABLET, DELAYED RELEASETrueAB1995-09-28DICLOFENAC SODIUM
2ANDA074376_002RXDICLOFENAC SODIUM (50MG)ORALTABLET, DELAYED RELEASETrueAB1995-09-28DICLOFENAC SODIUM
3ANDA074390_001discontinuedDICLOFENAC SODIUM (75MG)ORALTABLET, DELAYED RELEASEFalse1996-08-15DICLOFENAC SODIUM
4ANDA074391_001discontinuedDICLOFENAC SODIUM (25MG)ORALTABLET, DELAYED RELEASEFalse1995-06-29DICLOFENAC SODIUM
5ANDA074391_002discontinuedDICLOFENAC SODIUM (50MG)ORALTABLET, DELAYED RELEASEFalse1995-06-29DICLOFENAC SODIUM
6ANDA074391_003discontinuedDICLOFENAC SODIUM (75MG)ORALTABLET, DELAYED RELEASEFalse1995-06-29DICLOFENAC SODIUM
7ANDA074394_001RXDICLOFENAC SODIUM (75MG)ORALTABLET, DELAYED RELEASETrueAB1995-11-30DICLOFENAC SODIUM
8ANDA074432_002discontinuedDICLOFENAC SODIUM (50MG)ORALTABLET, DELAYED RELEASEFalse1999-07-29DICLOFENAC SODIUM
9ANDA074432_003discontinuedDICLOFENAC SODIUM (75MG)ORALTABLET, DELAYED RELEASEFalse1999-07-29DICLOFENAC SODIUM
10ANDA074459_001discontinuedDICLOFENAC SODIUM (25MG)ORALTABLET, DELAYED RELEASEFalse1997-06-25DICLOFENAC SODIUM
11ANDA074459_002discontinuedDICLOFENAC SODIUM (50MG)ORALTABLET, DELAYED RELEASEFalse1997-06-25DICLOFENAC SODIUM
12ANDA074459_003discontinuedDICLOFENAC SODIUM (75MG)ORALTABLET, DELAYED RELEASEFalse1997-06-25DICLOFENAC SODIUM
13ANDA074514_001RXDICLOFENAC SODIUM (50MG)ORALTABLET, DELAYED RELEASEFalseAB1996-03-26DICLOFENAC SODIUM
14ANDA074514_002RXDICLOFENAC SODIUM (75MG)ORALTABLET, DELAYED RELEASEFalseAB1996-03-26DICLOFENAC SODIUM
15ANDA074723_001discontinuedDICLOFENAC SODIUM (50MG)ORALTABLET, DELAYED RELEASEFalse1999-03-30DICLOFENAC SODIUM
16ANDA074986_001discontinuedDICLOFENAC SODIUM (50MG)ORALTABLET, DELAYED RELEASEFalse1999-02-26DICLOFENAC SODIUM
17ANDA074986_002discontinuedDICLOFENAC SODIUM (75MG)ORALTABLET, DELAYED RELEASEFalse1999-02-26DICLOFENAC SODIUM
18ANDA075185_001RXDICLOFENAC SODIUM (75MG)ORALTABLET, DELAYED RELEASEFalseAB1998-11-13DICLOFENAC SODIUM
19ANDA075185_002RXDICLOFENAC SODIUM (25MG)ORALTABLET, DELAYED RELEASEFalseAB1998-11-13DICLOFENAC SODIUM
20ANDA075185_003RXDICLOFENAC SODIUM (50MG)ORALTABLET, DELAYED RELEASEFalseAB1998-11-13DICLOFENAC SODIUM
21ANDA075281_002RXDICLOFENAC SODIUM (50MG)ORALTABLET, DELAYED RELEASEFalseAB2002-02-12DICLOFENAC SODIUM
22ANDA075281_003RXDICLOFENAC SODIUM (75MG)ORALTABLET, DELAYED RELEASEFalseAB2002-02-12DICLOFENAC SODIUM
23ANDA077863_003RXDICLOFENAC SODIUM (75MG)ORALTABLET, DELAYED RELEASEFalseAB2007-06-08DICLOFENAC SODIUM
24ANDA090066_001RXDICLOFENAC SODIUM (25MG)ORALTABLET, DELAYED RELEASEFalseAB2010-12-01DICLOFENAC SODIUM
25ANDA090066_002RXDICLOFENAC SODIUM (50MG)ORALTABLET, DELAYED RELEASEFalseAB2010-12-01DICLOFENAC SODIUM
26NDA019201_001discontinuedDICLOFENAC SODIUM (25MG)ORALTABLET, DELAYED RELEASEFalse1988-07-28VOLTAREN
27NDA019201_002discontinuedDICLOFENAC SODIUM (50MG)ORALTABLET, DELAYED RELEASEFalse1988-07-28VOLTAREN
28NDA019201_003discontinuedDICLOFENAC SODIUM (75MG)ORALTABLET, DELAYED RELEASEFalse1988-07-28VOLTAREN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10055edbf-f1f6-4b50-8e41-202c5a2a7883 (view SPL)Diclofenac Sodium Delayed-release Tablets, USP 40-8780 Revised March 2011prescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, Inc.Repack2012-07-191675440840, 675440899
205a94f49-3f12-462c-9180-ae75719d3441 (view SPL)Diclofenac SodiumDelayed-Release Tablets USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-01-241422540059
30c4281ab-1cd8-4e45-904c-9b9f5940c3bb (view SPL)Diclofenac Sodium Delayed-release Tablets, USP 50 mgprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcMANUFACTURE, REPACK2012-07-051433530784
417151304-01b7-1bed-e054-00144ff8d46c (view SPL)Diclofenac Sodium Delayed-release Tablets, USP 40-9184 Revised June 2012prescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-05-271105440114, 105440921
51877c2fb-39f7-45e3-b7f0-eb834ee273e4 (view SPL)Diclofenac Sodium Delayed-release Tablets, USP 40-9184 Revised June 2012prescriptionHuman PrescriptionDispensing Solutions, Inc.2013-10-292663360238
619b4ff5c-adb7-a0d0-7ef2-4ae05047fd94 (view SPL)Diclofenac Sodium Delayed-release Tablets, USP 25 mg and 50 mgprescriptionHuman PrescriptionAvkare, Inc.2015-07-3110422910230, 422910231
71b291d0a-1350-4637-bab3-f0bf43ab2a13 (view SPL)Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mgprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-12-131422540036
81b52cd67-bbc7-251f-e054-00144ff8d46c (view SPL)Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mgprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-09-022105440933
91bc60f67-86a4-4047-8a3b-ec1d16ebabca (view SPL)Diclofenac SodiumDelayed-Release Tablets USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-241521250505
101ea0a3ac-88ab-48c1-e054-00144ff8d46c (view SPL)Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mgprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-08-311105440934
111eb7a7bb-c524-4168-8ade-4601dc11533b (view SPL)Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mgprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-04-302631870012
12217f6c23-9a2e-4647-b4d2-ea9f9eb413c0 (view SPL)Diclofenac Sodium Delayed-release Tablets, USP 40-9184 Revised June 2012prescriptionHuman PrescriptionSt Marys Medical Park PharmacyMANUFACTURE, relabel2014-04-234607600788
1324845e58-5bfe-4a74-beec-696a564fb68c (view SPL)DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USPprescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationREPACK2011-07-011637390800
142840012a-3466-4a86-a316-d555f421e23b (view SPL)Diclofenac Sodium Delayed-release Tablets, USP 40-8780 Revised March 2011prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-241000636291535
1529d4e5e9-cfe7-44d4-9bd6-e4d376f65972 (view SPL)Diclofenac SodiumDelayed-Release Tablets USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-041521250297
162ae3c1e2-f053-4efb-9597-eeac4998d23f (view SPL)Diclofenac Sodium D/RprescriptionHuman PrescriptionDirect Rxrelabel, repack2014-03-211619190074, 619190075
172d92077c-75d2-4b34-8704-71660f77a63b (view SPL)DICLOFENAC SOD DRprescriptionHuman PrescriptionStat Rx Usa LlcRELABEL, REPACK2012-02-214425490510, 425490589
183330ea92-fc9d-4541-b378-be399b0995d3 (view SPL)Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mgprescriptionHuman PrescriptionPack Pharmaceuticals LlcMANUFACTURE2015-09-017165710201, 165710202, 165710203
1936ce096d-625f-4907-bfaa-49ac04dc7df1 (view SPL)Diclofenac Sodium Delayed-release Tablets, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-09-2712552890166
20381a14e5-65d3-487c-b0d2-b483b0d2824d (view SPL)Diclofenac Sodium Delayed-release Tablets, USP 40-9184 Revised June 2012prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2013-08-237430630566
2140879600-ba6c-43a8-aa5d-d0d41503d593 (view SPL)Diclofenac SodiumprescriptionHuman PrescriptionCarlsbad Technology, Inc.analysis, manufacture2015-09-047614420101, 614420102, 614420103
224b0d7319-a587-4648-bded-5b35b8efa1cb (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-07-207003786280, 003786281
235aaa3f1d-9792-4ce1-8895-9d5f3e871a2a (view SPL)Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mgprescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL, REPACK2013-10-182581180201, 581180212
245beea615-1892-41fb-8c39-3f70aa6ab63d (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2012-03-272493490937
25663a3dbc-a631-4046-8852-ec619c41c81d (view SPL)Diclofenac Sodium Delayed-release Tablets, USP 40-9184 Revised June 2012prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2013-08-237430630467
266b7fb6b7-2f58-4cb6-b48f-e9b4cf292365 (view SPL)DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-07-221216950038, 216950039
276fcb75a2-095d-424b-b9ac-f843a8e1d9b1 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2012-03-021493490888
2870c96b78-3702-4216-819f-1071770494bf (view SPL)DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USPprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2013-02-263006154506, 006154507
29716bf76f-ae98-498d-8960-0b35aa90c92b (view SPL)Diclofenac Sodium Delayed-release Tablets, USPprescriptionHuman PrescriptionCardinal HealthREPACK2011-05-161551543434
3073a46413-ecbc-4453-814d-bec955b375d2 (view SPL)Diclofenac Sodium Delayed-Release Tablets USPprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-09-012631870222
31770b5db0-3565-409d-a274-caa132fb8d89 (view SPL)Diclofenac Sodium Delayed-Release Tablets USPprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.RELABEL, REPACK2013-06-034105440189
327a7e69c1-6eea-4f27-b2ed-3e5fb176fdae (view SPL)Diclofenac SodiumDelayed-Release Tablets USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2013-12-311604290057, 604290058
337a7ee8e2-5137-4abf-9d75-5db51a69b88b (view SPL)Diclofenac Sodium Delayed-release Tablets, USPprescriptionHuman PrescriptionSandoz Inc2015-07-1315007811785, 007811787, 007811789
34807a0f13-93e5-4388-b3e9-5edc2a319640 (view SPL)Diclofenac Sodium Delayed-release Tablets, USPprescriptionHuman PrescriptionUnit Dose ServicesREPACK2011-06-061504361182
3587d5a720-f154-4c4b-b2d4-0ae58455dda0 (view SPL)Diclofenac Sodium Delayed-release Tablets, USP 40-8780 Revised March 2011prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-03-313552890150
368a33def9-169d-4370-ba72-9d7a4117530e (view SPL)Diclofenac SodiumDelayed-Release Tablets USPprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2012-04-103744499990089, 499990233
3796edaa7d-8c1c-46d1-8e80-b51072e55ed9 (view SPL)DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP 40-9184 Revised August 2015 Rx Only Prescribing InformationprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-10-292105440923
38a57b897e-0cbe-4ac3-969f-b00357a0cfa8 (view SPL)DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP 40-9184 Revised August 2015 Rx Only Prescribing InformationprescriptionHuman PrescriptionActavis Elizabeth LlcANALYSIS, LABEL, MANUFACTURE, PACK2015-08-0712002282550, 002282551
39a65aa738-8ce2-4276-8e54-5ecf4f461d3a (view SPL)Diclofenac Sodium Delayed-release Tablets, USPprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-11-072681512481
40bd27460e-46ff-4450-a4f2-a41420c1f93d (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-01-142548683659, 548683837, 548683999
41bfa8cb40-3528-4d41-ae77-444e521e30c0 (view SPL)Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-02-073965353560714, 353560725
42bfcd5d3b-30f8-4483-89e2-c67b41b22811 (view SPL)DICLOFENAC SODIUMprescriptionHuman PrescriptionNorthwind Pharmaceuticals, Llcrepack2015-01-261516550308
43c1cdbca7-8ea7-42c4-a8b5-c04ce0aadd09 (view SPL)Diclofenac SodiumDelayed-Release Tablets USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-12-041521250505
44c933eaad-ba53-4130-90db-a66f89dfc29f (view SPL)Diclofenac Sodium Delayed-Release Tablets USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-08-311687889806
45cbdc93dd-860a-4bf7-b86f-5c9c9e2e553b (view SPL)Diclofenac Sodium Delayed-release Tablets, USPprescriptionHuman PrescriptionBluepoint LaboratoriesMANUFACTURE2015-08-174680010200, 680010201, 680010202
46cc715a60-32e0-4d31-a1df-2a591a56d4e5 (view SPL)Diclofenac Sodium Delayed-Release Tablets USPprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.RELABEL, REPACK2013-12-311105440188
47d207da6e-d074-4dab-95f1-265b1df41aea (view SPL)diclofenac sodium (Diclofenac Sodium) tabletprescriptionHuman PrescriptionStat Rx Usa Llc2009-10-272165900074
48d44134d1-2ca9-4249-872c-65a7186870c8 (view SPL)Diclofenac Sodium Delayed-Release Tablets USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-07-274680840333
49df63e944-bfb7-453d-bbd8-63f545826784 (view SPL)Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mgprescriptionHuman PrescriptionPack Pharmaceuticals LlcANALYSIS, MANUFACTURE2014-11-126165710201
50e424b30d-8f40-48b7-bb99-415f92d84ed0 (view SPL)Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mgprescriptionHuman PrescriptionH.J. Harkins Company, Inc.analysis, manufacture2012-04-193529590423
51e780534f-5b33-42f8-ae35-ccf8ee652035 (view SPL)Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mgprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-09-224687889175, 687889231
52e8527a76-4efc-4ead-a11d-87252693fa36 (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2015-07-033510790224, 510790466
53eff16712-d4c4-4e7b-bf38-c467de1095f4 (view SPL)Diclofenac Sodium Delayed-release Tablets, USP 75 mgprescriptionHuman PrescriptionKeltman Pharmaceuticals Inc.repack2010-06-111683870260
54f0e00d55-02b7-4642-a60e-6a5841932ca5 (view SPL)Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mgprescriptionHuman PrescriptionUnit Dose ServicesREPACK2011-09-013504366924
55f32c0225-fd21-468a-90f5-6083071e80fb (view SPL)prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-11-254687889185
56f5b4e308-c156-4865-95ee-1a8e267535ba (view SPL)DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP 40-9184 Revised August 2015 Rx Only Prescribing InformationprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870522
57f674ad5c-b022-463a-af41-05bb03ee171b (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-06-021493490276
58f940aa00-2a88-44ce-b36f-fd51552b2c2b (view SPL)Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mgprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-07-031663360463

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII