Etodolac Oral Capsule

Brand(s)
Lodine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Taro Pharmaceuticals U.S.A., Inc. (2015-10-21)
Oldest Current Product
1998-04-05
License(s)
ANDA
RxNORM
ORAL CAPSULE\ETODOLAC
FDAOB
ORAL\CAPSULE\ETODOLAC
ORAL\TABLET\ETODOLAC
SPL Active
ORAL\CAPSULE, GELATIN COATED\ETODOLAC
ORAL\CAPSULE\ETODOLAC
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\ETODOLAC
ORAL\CAPSULE\ETODOLAC

product(s) by strength(s)

etodolac 200 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1516724016ANDATaro Pharmaceuticals U.S.A., Inc.1998-04-30ETODOLACORALCAPSULEANDA075078ec82b108-6a6f-4d1b-82cb-831d4ed36c80
2605050039ANDAApotex Corp2003-05-01ETODOLACORALCAPSULEANDA07541986c7b7b8-3a98-e5f4-c558-5b5caede6377
3625590250ANDAAnip Acquisition Company2015-03-09ETODOLACORALCAPSULEANDA075126420c7b62-3bea-4d6b-82e0-ab1c176c7f1e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001791579ANDAKaiser Foundations Hospitals2005-12-01ETODOLACORALCAPSULE516724016ANDA075078fefce35b-b8a1-40c2-a3f2-528d0cbeab24
2433530918ANDAAphena Pharma Solutions - Tennessee, Llc1998-04-05ETODOLACORALCAPSULE604290243ANDA075078c9f3dc18-d81c-4b02-8ff4-240c247bcbdd
3548685274ANDAPhysicians Total Care, Inc.2005-04-27ETODOLACORALCAPSULE516724016ANDA0750784b5513c3-b57f-46f1-9855-dad1063aa4c9
4604290243ANDAGolden State Medical Supply, Inc.1998-04-05ETODOLACORALCAPSULE516724016ANDA075078cf17926c-ed90-4fd0-80af-ccee084075e8

etodolac 300 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1516724017ANDATaro Pharmaceuticals U.S.A., Inc.1998-04-30ETODOLACORALCAPSULEANDA075078ec82b108-6a6f-4d1b-82cb-831d4ed36c80
2605050040ANDAApotex Corp2003-05-01ETODOLACORALCAPSULEANDA07541986c7b7b8-3a98-e5f4-c558-5b5caede6377
3625590251ANDAAnip Acquisition Company2015-02-01ETODOLACORALCAPSULEANDA075126420c7b62-3bea-4d6b-82e0-ab1c176c7f1e

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900488ANDAStat Rx Usa Llc1998-04-30ETODOLACORALCAPSULE516724017ANDA075078816576ac-c49d-4762-9722-e30493d6af83
2216950049ANDARebel Distributors Corp1999-09-16ETODOLACORALCAPSULE, GELATIN COATED000938397ANDA075126db60911a-2bb1-4e8c-baf0-7cf281bf5778
3353560616ANDALake Erie Medical Dba Quality Care Products Llc2012-03-06ETODOLACORALCAPSULE516724017ANDA07507865b5d8e3-8dcc-4297-ae85-5b5cb7c81f61
4422540121ANDARebel Distributors Corp2010-03-31ETODOLACORALCAPSULE516724017ANDA0750789c244c88-dcc4-44fb-b0d9-13732dc705f5
5433530753ANDAAphena Pharma Solutions - Tennessee, Llc1998-04-05ETODOLACORALCAPSULE604290244ANDA075078c9f3dc18-d81c-4b02-8ff4-240c247bcbdd
6493490019ANDARemedyrepack Inc.2010-10-06ETODOLACORALCAPSULE605050040ANDA0754199b78a9d6-5600-4e01-83d9-bd348b110cf6
7493490331ANDARemedyrepack Inc.2011-06-27ETODOLACORALCAPSULE516724017ANDA0750789514418a-0020-442d-9227-0241a989d6e4
8504360263ANDAUnit Dose Services1998-04-30ETODOLACORALCAPSULE516724017ANDA07507817c8639e-f1ae-4733-992c-27506591871e
9516550166ANDANorthwind Pharmaceuticals, Llc2014-11-13ETODOLACORALCAPSULE605050040ANDA0754197ec87ffd-057e-420c-b8f2-0a6eed4152be
10548684135ANDAPhysicians Total Care, Inc.2010-03-31ETODOLACORALCAPSULE516724017ANDA0750784b5513c3-b57f-46f1-9855-dad1063aa4c9
11552890501ANDAPd-Rx Pharmaceuticals, Inc.1998-04-30ETODOLACORALCAPSULE516724017ANDA0750788966c049-dc10-4522-9d97-abee99334c3d
12604290244ANDAGolden State Medical Supply, Inc.1998-04-05ETODOLACORALCAPSULE516724017ANDA075078cf17926c-ed90-4fd0-80af-ccee084075e8
13636291376LodineANDABryant Ranch Prepack2009-06-30ETODOLACORALCAPSULE, GELATIN COATED000938397ANDA07512686719bea-90f8-4696-ad0c-10a31967c850
14687889930ANDAPreferred Pharmaceuticals, Inc.2012-01-17ETODOLACORALCAPSULE516724017ANDA07507827236095-98b3-4588-9840-f247a7e29207

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA074840ETODOLACTrueSANDOZ INC1997-08-29ANDA074840_001, ANDA074840_002
2ANDA074842ETODOLACTrueVINTAGE PHARMACEUTICALS LLC1997-07-17ANDA074842_001, ANDA074842_002
3ANDA074844ETODOLACTrueWATSON LABORATORIES INC1997-12-23ANDA074844_001, ANDA074844_002
4ANDA074899ETODOLACTrueANI PHARMACEUTICALS INC1997-07-08ANDA074899_001, ANDA074899_002
5ANDA074929ETODOLACTrueAAIPHARMA LLC1998-01-30ANDA074929_001
6ANDA074932ETODOLACTrueMYLAN PHARMACEUTICALS INC1997-05-16ANDA074932_001, ANDA074932_002
7ANDA074942ETODOLACTrueSANDOZ INC1997-09-30ANDA074942_001, ANDA074942_002
8ANDA075071ETODOLACTrueMYLAN PHARMACEUTICALS INC1998-09-30ANDA075071_001, ANDA075071_002
9ANDA075078ETODOLACTARO PHARMACEUTICAL INDUSTRIES LTD1998-04-30ANDA075078_001, ANDA075078_002
10ANDA075126ETODOLACANI PHARMACEUTICALS INC1999-09-16ANDA075126_001, ANDA075126_002
11ANDA075419ETODOLACAPOTEX INC2000-07-28ANDA075419_001, ANDA075419_002
12NDA018922LODINETrueWYETH PHARMACEUTICALS INC1991-01-31NDA018922_002, NDA018922_003, NDA018922_004, NDA018922_005Etodolac Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074840_001discontinuedETODOLAC (200MG)ORALCAPSULEFalse1997-08-29ETODOLAC
2ANDA074840_002discontinuedETODOLAC (300MG)ORALCAPSULEFalse1997-08-29ETODOLAC
3ANDA074842_001discontinuedETODOLAC (200MG)ORALCAPSULEFalse1997-07-17ETODOLAC
4ANDA074842_002discontinuedETODOLAC (300MG)ORALCAPSULEFalse1997-07-17ETODOLAC
5ANDA074844_001discontinuedETODOLAC (200MG)ORALCAPSULEFalse1997-12-23ETODOLAC
6ANDA074844_002discontinuedETODOLAC (300MG)ORALCAPSULEFalse1997-12-23ETODOLAC
7ANDA074899_001discontinuedETODOLAC (200MG)ORALCAPSULEFalse1997-07-08ETODOLAC
8ANDA074899_002discontinuedETODOLAC (300MG)ORALCAPSULEFalse1997-07-08ETODOLAC
9ANDA074929_001discontinuedETODOLAC (300MG)ORALCAPSULEFalse1998-01-30ETODOLAC
10ANDA074932_001discontinuedETODOLAC (200MG)ORALCAPSULEFalse1997-05-16ETODOLAC
11ANDA074932_002discontinuedETODOLAC (300MG)ORALCAPSULEFalse1997-05-16ETODOLAC
12ANDA074942_001discontinuedETODOLAC (200MG)ORALCAPSULEFalse1997-09-30ETODOLAC
13ANDA074942_002discontinuedETODOLAC (300MG)ORALCAPSULEFalse1997-09-30ETODOLAC
14ANDA075071_001discontinuedETODOLAC (200MG)ORALCAPSULEFalse1998-09-30ETODOLAC
15ANDA075071_002discontinuedETODOLAC (300MG)ORALCAPSULEFalse1998-09-30ETODOLAC
16ANDA075078_001RXETODOLAC (200MG)ORALCAPSULEFalseAB1998-04-30ETODOLAC
17ANDA075078_002RXETODOLAC (300MG)ORALCAPSULETrueAB1998-04-30ETODOLAC
18ANDA075126_001RXETODOLAC (200MG)ORALCAPSULEFalseAB1999-09-16ETODOLAC
19ANDA075126_002RXETODOLAC (300MG)ORALCAPSULEFalseAB1999-09-16ETODOLAC
20ANDA075419_001RXETODOLAC (200MG)ORALCAPSULEFalseAB2000-07-28ETODOLAC
21ANDA075419_002RXETODOLAC (300MG)ORALCAPSULEFalseAB2000-07-28ETODOLAC
22NDA018922_002discontinuedETODOLAC (200MG)ORALCAPSULEFalse1991-01-31LODINE
23NDA018922_003discontinuedETODOLAC (300MG)ORALCAPSULEFalse1991-01-31LODINE
24NDA018922_004discontinuedETODOLAC (400MG)ORALTABLETFalse1993-07-29LODINE
25NDA018922_005discontinuedETODOLAC (500MG)ORALTABLETFalse1996-06-28LODINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
117c8639e-f1ae-4733-992c-27506591871e (view SPL)Etodolac Capsules and Tablets, USPprescriptionHuman PrescriptionUnit Dose ServicesREPACK2011-12-082504360263
227236095-98b3-4588-9840-f247a7e29207 (view SPL)Etodolac Capsules and Tablets, USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-03-042687889930, 687889929Etodolac Oral Tablet
3420c7b62-3bea-4d6b-82e0-ab1c176c7f1e (view SPL)Etodolac Capsules USP Rx onlyprescriptionHuman PrescriptionAnip Acquisition CompanyANALYSIS, LABEL, MANUFACTURE, PACK2015-08-073625590250, 625590251
44b5513c3-b57f-46f1-9855-dad1063aa4c9 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-04-072548684135, 548685274, 548683955, 548684059Etodolac Oral Tablet
565b5d8e3-8dcc-4297-ae85-5b5cb7c81f61 (view SPL)Etodolac Capsules, Tablets and ER Tablets, USPprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2012-03-063619353560616
67ec87ffd-057e-420c-b8f2-0a6eed4152be (view SPL)ETODOLACprescriptionHuman PrescriptionNorthwind Pharmaceuticals, Llcrepack2014-11-131516550166
7816576ac-c49d-4762-9722-e30493d6af83 (view SPL)Etodolac Capsules and Tablets, USPprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-06-152165900488, 165900092Etodolac Oral Tablet
886719bea-90f8-4696-ad0c-10a31967c850 (view SPL)Etodolac 300mg CapsuleprescriptionHuman PrescriptionBryant Ranch Prepackrepack2012-10-122636291376
986c7b7b8-3a98-e5f4-c558-5b5caede6377 (view SPL)Etodolac Capsules, USP 200 mg and 300 mgprescriptionHuman PrescriptionApotex Corpanalysis, manufacture2015-07-282605050039, 605050040
108966c049-dc10-4522-9d97-abee99334c3d (view SPL)Etodolac Capsules and Tablets, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-12-082552890501
119514418a-0020-442d-9227-0241a989d6e4 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-06-272493490331
129b78a9d6-5600-4e01-83d9-bd348b110cf6 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2010-10-0631493490019
139c244c88-dcc4-44fb-b0d9-13732dc705f5 (view SPL)prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-01-101422540121
14c9f3dc18-d81c-4b02-8ff4-240c247bcbdd (view SPL)Etodolac Capsules, Tablets and ER Tablets, USPprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-05-301433530753, 433530918, 433530749, 433530752Etodolac Oral Tablet
15cf17926c-ed90-4fd0-80af-ccee084075e8 (view SPL)Etodolac Capsules, Tablets and ER Tablets, USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-07-013604290243, 604290244, 604290311, 604290312, 604290313, 604290314, 604290315Etodolac Extended Release Oral Tablet
Etodolac Oral Tablet
16db60911a-2bb1-4e8c-baf0-7cf281bf5778 (view SPL)ETODOLAC CAPSULES USP8397prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-271216950049
17ec82b108-6a6f-4d1b-82cb-831d4ed36c80 (view SPL)Etodolac Capsules and Tablets, USPprescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2015-10-214516724016, 516724017, 516724018, 516724036Etodolac Oral Tablet
18fefce35b-b8a1-40c2-a3f2-528d0cbeab24 (view SPL)Etodolac Capsules and Tablets, USPprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2015-01-161001791579, 001791497Etodolac Oral Tablet

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