Application 091276

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INDOMETHACININDOMETHACINCAPSULE;ORAL25MGNoNo
002INDOMETHACININDOMETHACINCAPSULE;ORAL50MGNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091276-001INDOMETHACININDOMETHACIN25MGCAPSULE / ORALAB2010-12-22
A091276-002INDOMETHACININDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A091276-001AB
A091276-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-2284e616aacf4f…
2026-09-14 22:38:342026-08A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-2284e616aacf4f…
2026-08-18 06:07:402026-07A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-2274a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A091276-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A091276-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A091276-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091276-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091276-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091276-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091276-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091276-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091276-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091276-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091276-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091276-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091276-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091276-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091276-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091276-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091276-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091276-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091276-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091276-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091276-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091276-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091276-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091276-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091276-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091276-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091276-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091276-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091276-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091276-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091276-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091276-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091276-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091276-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091276-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091276-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091276-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091276-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091276-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091276-002AB174a2ff9319b5…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IndomethacinINDOMETHACINProficient Rx LPb094eb04-3177-431d-b5ac-edc4804750a22022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 132 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-083IndomethacinIndomethacinBlenheim Pharmacal, Inc.ANDACurrent
21695-522IndomethacinIndomethacinRebel Distributors CorpANDACurrent
35356-697IndomethacinIndomethacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-697IndomethacinIndomethacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-697IndomethacinIndomethacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-697IndomethacinIndomethacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
42254-081IndomethacinIndomethacinRebel Distributors CorpANDACurrent
43063-368IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-368IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-368IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-368IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-368IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-929IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-929IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-929IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-929IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-929IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-929IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-929IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-930IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-930IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-930IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-930IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-930IndomethacinIndomethacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0054IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-0054IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-0054IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-0054IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-0054IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-0055IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-0055IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-0055IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-0055IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-2803IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-2803IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-2803IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-2803IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-2987IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-2987IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
50090-2987IndomethacinIndomethacinA-S Medication SolutionsANDACurrent
51655-329IndomethacinIndomethacinNorthwind Pharmaceuticals, LLCANDACurrent
53002-3051IndomethacinIndomethacinRPK Pharmaceuticals, Inc.ANDACurrent
53002-3500IndomethacinIndomethacinRPK Pharmaceuticals, Inc.ANDACurrent
53002-3500IndomethacinIndomethacinRPK Pharmaceuticals, Inc.ANDACurrent
60760-294IndomethacinIndomethacinSt. Mary's Medical Park PharmacyANDACurrent
61919-164INDOMETHACININDOMETHACINDIRECT RXANDACurrent
61919-164INDOMETHACININDOMETHACINDIRECT RXANDACurrent
61919-164INDOMETHACININDOMETHACINDIRECT RXANDACurrent
61919-164INDOMETHACININDOMETHACINDIRECT RXANDACurrent
61919-526INDOMETHACININDOMETHACINDIRECT RXANDACurrent
61919-526INDOMETHACININDOMETHACINDIRECT RXANDACurrent
61919-526INDOMETHACININDOMETHACINDIRECT RXANDACurrent
63187-948IndomethacinIndomethacinProficient Rx LPANDACurrent
63187-948IndomethacinIndomethacinProficient Rx LPANDACurrent
63187-948IndomethacinIndomethacinProficient Rx LPANDACurrent
63629-7679IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
63629-7679IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
63629-7679IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
67296-0723IndomethacinIndomethacinRedPharm Drug, Inc.ANDACurrent
67296-0723IndomethacinIndomethacinRedPharm Drug, Inc.ANDACurrent
67296-0723IndomethacinIndomethacinRedPharm Drug, Inc.ANDACurrent
67296-0886IndomethacinIndomethacinRedPharm Drug, Inc.ANDACurrent
67296-0886IndomethacinIndomethacinRedPharm Drug, Inc.ANDACurrent
67296-0886IndomethacinIndomethacinRedPharm Drug, Inc.ANDACurrent
68071-3277IndomethacinIndomethacinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3277IndomethacinIndomethacinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3277IndomethacinIndomethacinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3277IndomethacinIndomethacinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4394IndomethacinIndomethacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4394IndomethacinIndomethacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4394IndomethacinIndomethacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5269IndomethacinIndomethacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5269IndomethacinIndomethacinNuCare Pharmaceuticals,Inc.ANDACurrent
68151-0279IndomethacinIndomethacinCarilion Materials ManagementANDACurrent
68462-302IndomethacinIndomethacinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-302IndomethacinIndomethacinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-302IndomethacinIndomethacinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-302IndomethacinIndomethacinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-302IndomethacinIndomethacinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-302IndomethacinIndomethacinGlenmark Pharmaceuticals Inc., USAANDACurrent