rabeprazole Delayed Release Oral Tablet

Brand(s)
Aciphex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eisai Inc. (2014-12-30)
Oldest Current Product
1999-08-19
License(s)
NDA, ANDA
RxNORM
DELAYED RELEASE ORAL TABLET\RABEPRAZOLE
FDAOB
ORAL\TABLET, DELAYED RELEASE\RABEPRAZOLE SODIUM
SPL Active
ORAL\TABLET, COATED\RABEPRAZOLE SODIUM
ORAL\TABLET, DELAYED RELEASE\RABEPRAZOLE SODIUM
SPL Moiety
ORAL\TABLET, COATED\RABEPRAZOLE
ORAL\TABLET, DELAYED RELEASE\RABEPRAZOLE

product(s) by strength(s)

rabeprazole sodium 20 mg delayed release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1628560243AciphexNDAEisai Inc.1999-08-19RABEPRAZOLE SODIUMORALTABLET, DELAYED RELEASENDA0209735d103551-978f-472a-9c62-51e6e4dea068

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930064ANDATeva Pharmaceuticals Usa Inc2013-11-08RABEPRAZOLE SODIUMORALTABLET, DELAYED RELEASEANDA076822c4b47fe4-3f9f-48e4-ab73-d66be828c52b
2003786709ANDAMylan Pharmaceuticals Inc.2013-11-08RABEPRAZOLE SODIUMORALTABLET, DELAYED RELEASEANDA076885e2aee698-2993-4a21-b273-791d2e40f9e8
3136680107ANDATorrent Pharmaceuticals Limited2013-11-08RABEPRAZOLE SODIUMORALTABLET, DELAYED RELEASEANDA20237604e88b86-e1dd-4c56-8359-45fbcc161f7d
4621750302ANDAKremers Urban Pharmaceuticals Inc.2013-11-08RABEPRAZOLE SODIUMORALTABLET, DELAYED RELEASEANDA0906787f7d68f0-972b-4315-b712-0bb8a84c85cc
5651620724ANDAAmneal Pharmaceuticals2015-10-01RABEPRAZOLE SODIUMORALTABLET, DELAYED RELEASEANDA204179951caefe-6e18-48ff-9567-beb545b09c25
6681800220ANDALupin Pharmaceuticals, Inc.2013-11-08RABEPRAZOLE SODIUMORALTABLET, DELAYED RELEASEANDA078964ab79631b-9f64-4381-a91a-6c4973be709e

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1009046375ANDAMajor2013-11-08RABEPRAZOLE SODIUMORALTABLET, DELAYED RELEASE136680107ANDA2023763d58300e-cfde-4e33-9f85-7a3c5c8d0c0d
2422910721ANDAAvkare, Inc.2013-12-23RABEPRAZOLE SODIUMORALTABLET, DELAYED RELEASE000930064ANDA076822b123b66b-82e8-e10a-392e-b44bd775d8d8
3422910722ANDAAvkare, Inc.2013-12-19RABEPRAZOLE SODIUMORALTABLET, DELAYED RELEASE621750302ANDA0906784f2ef109-eee2-3018-a6d4-b0ea1ad72609
4499990447AciphexNDALake Erie Medical Dba Quality Care Products Llc2012-02-17, 2012-02-29RABEPRAZOLE SODIUMORALTABLET, COATED628560243NDA0209730eed7378-67a4-4b08-aeea-32471ce2028e, 6e6f6c6d-4826-4817-90ff-5c3f4fbe8909
5504360302ANDAUnit Dose Services2013-11-08RABEPRAZOLE SODIUMORALTABLET, DELAYED RELEASE621750302ANDA0906788699d125-0928-458f-a232-9864497c73cb
6548684185AciphexNDAPhysicians Total Care, Inc.2000-05-15RABEPRAZOLE SODIUMORALTABLET, DELAYED RELEASE628560243NDA020973dbfa7ae4-35af-4ed3-bca4-7900cd92047c
7551542451AciphexNDACardinal Health1999-08-19RABEPRAZOLE SODIUMORALTABLET, COATED628560243NDA02097352459f70-e1f5-41bb-a9f4-e68ef5f5dcf5
8604290232ANDAGolden State Medical Supply, Inc.2015-03-02RABEPRAZOLE SODIUMORALTABLET, DELAYED RELEASE003786709ANDA076885426724dd-c619-4160-b859-5496a90a7837
9631870158ANDAProficient Rx Lp2013-11-08RABEPRAZOLE SODIUMORALTABLET, DELAYED RELEASE003786709ANDA0768854dc7a892-2419-4850-b691-e03ecc2e75f7
10631870259ANDAProficient Rx Lp2013-11-08RABEPRAZOLE SODIUMORALTABLET, DELAYED RELEASE621750302ANDA09067814412af6-e99c-4264-bc34-28a6f139f252
11631870555ANDAProficient Rx Lp2013-11-08RABEPRAZOLE SODIUMORALTABLET, DELAYED RELEASE136680107ANDA202376d1444508-fe40-4f68-8350-52f13399e38a
12636292733AciphexNDABryant Ranch Prepack1999-08-19RABEPRAZOLE SODIUMORALTABLET, COATED628560243NDA020973c03c0f10-4bd6-4181-9c2a-99facaa0ab1c
13681513834AciphexNDACarilion Materials Management1999-08-19RABEPRAZOLE SODIUMORALTABLET, DELAYED RELEASE628560243NDA020973001dd372-2692-4d6f-a71c-95e7056349a9
14687888911ANDAPreferred Pharmaceuticals, Inc.2015-08-27RABEPRAZOLE SODIUMORALTABLET, DELAYED RELEASE000930064ANDA0768220a00adf2-5c45-4eb1-a03e-8d37980f8633
15687889275ANDAPreferred Pharmaceuticals, Inc.2015-05-13RABEPRAZOLE SODIUMORALTABLET, DELAYED RELEASE136680107ANDA2023764ba56c0d-ec48-4fe0-a0c2-6edb820a4695

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA076822RABEPRAZOLE SODIUMTEVA PHARMACEUTICALS USA INC2013-11-08ANDA076822_001
2ANDA076824RABEPRAZOLE SODIUMDR REDDYS LABORATORIES LTD2013-11-08ANDA076824_001
3ANDA076885RABEPRAZOLE SODIUMMYLAN PHARMACEUTICALS INC2013-11-08ANDA076885_001
4ANDA078964RABEPRAZOLE SODIUMLUPIN LTD2013-11-08ANDA078964_001
5ANDA090678RABEPRAZOLE SODIUMKREMERS URBAN DEVELOPMENT CO2013-11-08ANDA090678_001
6ANDA202376RABEPRAZOLE SODIUMTORRENT PHARMACEUTICALS LTD2013-11-08ANDA202376_001
7ANDA204179RABEPRAZOLE SODIUMAMNEAL PHARMACEUTICALS2015-07-31ANDA204179_001
8NDA020973ACIPHEXEISAI INC1999-08-19NDA020973_001, NDA020973_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076822_001RXRABEPRAZOLE SODIUM (20MG)ORALTABLET, DELAYED RELEASEFalseAB2013-11-08RABEPRAZOLE SODIUM
2ANDA076824_001RXRABEPRAZOLE SODIUM (20MG)ORALTABLET, DELAYED RELEASEFalseAB2013-11-08RABEPRAZOLE SODIUM
3ANDA076885_001RXRABEPRAZOLE SODIUM (20MG)ORALTABLET, DELAYED RELEASEFalseAB2013-11-08RABEPRAZOLE SODIUM
4ANDA078964_001RXRABEPRAZOLE SODIUM (20MG)ORALTABLET, DELAYED RELEASEFalseAB2013-11-08RABEPRAZOLE SODIUM
5ANDA090678_001RXRABEPRAZOLE SODIUM (20MG)ORALTABLET, DELAYED RELEASEFalseAB2013-11-08RABEPRAZOLE SODIUM
6ANDA202376_001RXRABEPRAZOLE SODIUM (20MG)ORALTABLET, DELAYED RELEASEFalseAB2013-11-08RABEPRAZOLE SODIUM
7ANDA204179_001RXRABEPRAZOLE SODIUM (20MG)ORALTABLET, DELAYED RELEASEFalseAB2015-07-31RABEPRAZOLE SODIUM
8NDA020973_001discontinuedRABEPRAZOLE SODIUM (10MG)ORALTABLET, DELAYED RELEASEFalse2002-05-29ACIPHEX
9NDA020973_002RXRABEPRAZOLE SODIUM (20MG)ORALTABLET, DELAYED RELEASETrueAB1999-08-19ACIPHEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1001dd372-2692-4d6f-a71c-95e7056349a9 (view SPL)These highlights do not include all the information needed to use ACIPHEX safely and effectively. See full prescribing information for ACIPHEX. ACIPHEX (rabeprazole sodium) Delayed-Release Tablets, for oral use ACIPHEX Sprinkle (rabeprazole sodium) Delayed-Release Capsules, for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-03-152681513834
204e88b86-e1dd-4c56-8359-45fbcc161f7d (view SPL)These highlights do not include all the information needed to use rabeprazole sodium delayed-release tablets safely and effectively. See full prescribing information for rabeprazole sodium delayed-release tablets. RABEPRAZOLE Sodium Delayed-Release Tablets, for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionTorrent Pharmaceuticals LimitedManufacture2014-10-162136680107
30a00adf2-5c45-4eb1-a03e-8d37980f8633 (view SPL)These highlights do not include all the information needed to use rabeprazole sodium delayed-release tablets safely and effectively. See full prescribing information for rabeprazole sodium delayed-release tablets. RABEPRAZOLE sodium delayed-release tablets, for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-08-271687888911
40eed7378-67a4-4b08-aeea-32471ce2028e (view SPL)These highlights do not include all the information needed to use ACIPHEX safely and effectively. See full prescribing information for ACIPHEX. ACIPHEX (rabeprazole sodium) Delayed-Release Tablets Initial U.S. Approval: 1999prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcmanufacture, relabel, repack2012-02-173575499990447
514412af6-e99c-4264-bc34-28a6f139f252 (view SPL)These highlights do not include all the information needed to use rabeprazole sodium delayed-release tablets safely and effectively. See full prescribing information for rabeprazole sodium delayed-release tablets. RABEPRAZOLE sodium delayed-release tablets, for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-10-012631870259
63d58300e-cfde-4e33-9f85-7a3c5c8d0c0d (view SPL)These highlights do not include all the information needed to use rabeprazole sodium delayed-release tablets safely and effectively. See full prescribing information for rabeprazole sodium delayed-release tablets. RABEPRAZOLE Sodium Delayed-Release Tablets, for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionMajor2014-01-131009046375
7426724dd-c619-4160-b859-5496a90a7837 (view SPL)These highlights do not include all the information needed to use rabeprazole sodium delayed-release tablets safely and effectively. See full prescribing information for rabeprazole sodium delayed-release tablets.RABEPRAZOLE sodium delayed-release tablets, for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2015-09-081604290232
84ba56c0d-ec48-4fe0-a0c2-6edb820a4695 (view SPL)These highlights do not include all the information needed to use rabeprazole sodium delayed-release tablets safely and effectively. See full prescribing information for rabeprazole sodium delayed-release tablets. RABEPRAZOLE Sodium Delayed-Release Tablets, for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-05-131687889275
94dc7a892-2419-4850-b691-e03ecc2e75f7 (view SPL)These highlights do not include all the information needed to use rabeprazole sodium delayed-release tablets safely and effectively. See full prescribing information for rabeprazole sodium delayed-release tablets.Rabeprazole Sodium Delayed-release Tablets, for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-08-012631870158
104f2ef109-eee2-3018-a6d4-b0ea1ad72609 (view SPL)These highlights do not include all the information needed to use rabeprazole sodium delayed-release tablets safely and effectively. See full prescribing information for rabeprazole sodium delayed-release tablets. RABEPRAZOLE sodium delayed-release tablets, for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionAvkare, Inc.2015-11-043422910722
1152459f70-e1f5-41bb-a9f4-e68ef5f5dcf5 (view SPL)These highlights do not include all the information needed to use Aciphex safely and effectively. See full prescribing information for Aciphex. ACIPHEX (rabeprazole sodium) Delayed-Release Tablets Initial U.S. Approval: 1999prescriptionHuman PrescriptionCardinal HealthREPACK2013-11-116551542451
125d103551-978f-472a-9c62-51e6e4dea068 (view SPL)These highlights do not include all the information needed to use ACIPHEX safely and effectively. See full prescribing information for ACIPHEX. ACIPHEX (rabeprazole sodium) Delayed-Release Tablets, for oral use ACIPHEX Sprinkle (rabeprazole sodium) Delayed-Release Capsules, for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionEisai Inc.2014-12-3023628560243
136e6f6c6d-4826-4817-90ff-5c3f4fbe8909 (view SPL)These highlights do not include all the information needed to use ACIPHEX safely and effectively. See full prescribing information for ACIPHEX. ACIPHEX (rabeprazole sodium) Delayed-Release Tablets Initial U.S. Approval: 1999prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2012-03-013607499990447
147f7d68f0-972b-4315-b712-0bb8a84c85cc (view SPL)These highlights do not include all the information needed to use rabeprazole sodium delayed-release tablets safely and effectively. See full prescribing information for rabeprazole sodium delayed-release tablets. RABEPRAZOLE sodium delayed-release tablets, for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionKremers Urban Pharmaceuticals Inc.2015-01-1311621750302
158699d125-0928-458f-a232-9864497c73cb (view SPL)These highlights do not include all the information needed to use rabeprazole sodium delayed-release tablets safely and effectively. See full prescribing information for rabeprazole sodium delayed-release tablets. RABEPRAZOLE sodium delayed-release tablets, for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionUnit Dose ServicesREPACK2013-10-182504360302
16951caefe-6e18-48ff-9567-beb545b09c25 (view SPL)These highlights do not include all the information needed to use rabeprazole sodium safely and effectively. See full prescribing information for rabeprazole sodium. RABEPRAZOLE sodium delayed-release tablets, for oral use.Initial U.S. Approval: 1999prescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2015-07-3010651620724
17ab79631b-9f64-4381-a91a-6c4973be709e (view SPL)These highlights do not include all the information needed to use rabeprazole sodium delayed-release tablets safely and effectively. See full prescribing information for rabeprazole sodium delayed-release tablets.RABEPRAZOLE sodium delayed-release tablets, for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.2015-01-019681800220
18b123b66b-82e8-e10a-392e-b44bd775d8d8 (view SPL)These highlights do not include all the information needed to use rabeprazole sodium delayed-release tablets safely and effectively. See full prescribing information for rabeprazole sodium delayed-release tablets.RABEPRAZOLE sodium delayed-release tablets, for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionAvkare, Inc.2014-02-192422910721
19c03c0f10-4bd6-4181-9c2a-99facaa0ab1c (view SPL)These highlights do not include all the information needed to use Aciphex safely and effectively. See full prescribing information for Aciphex. ACIPHEX (rabeprazole sodium) Delayed-Release Tablets Initial U.S. Approval: 1999prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-281001636292733
20c4b47fe4-3f9f-48e4-ab73-d66be828c52b (view SPL)These highlights do not include all the information needed to use rabeprazole sodium delayed-release tablets safely and effectively. See full prescribing information for rabeprazole sodium delayed-release tablets. RABEPRAZOLE sodium delayed-release tablets, for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-04-164000930064
21d1444508-fe40-4f68-8350-52f13399e38a (view SPL)These highlights do not include all the information needed to use rabeprazole sodium delayed-release tablets safely and effectively. See full prescribing information for rabeprazole sodium delayed-release tablets. RABEPRAZOLE Sodium Delayed-Release Tablets, for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870555
22dbfa7ae4-35af-4ed3-bca4-7900cd92047c (view SPL)These highlights do not include all the information needed to use ACIPHEX safely and effectively. See full prescribing information for ACIPHEX. ACIPHEX (rabeprazole sodium) tablet, delayed release for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-11-102548684185
23e2aee698-2993-4a21-b273-791d2e40f9e8 (view SPL)These highlights do not include all the information needed to use rabeprazole sodium delayed-release tablets safely and effectively. See full prescribing information for rabeprazole sodium delayed-release tablets.RABEPRAZOLE sodium delayed-release tablets, for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-04-297003786709

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