FDA.reportPublic FDA data

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 1.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22a50c72e98297…
2026-08-01 22:54:322026-06A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091276-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A091276-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IndomethacinINDOMETHACINREMEDYREPACK INC.bf93022c-a965-49c5-a852-c59e580d7d912026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.009097a5-2c1e-4f5d-8054-896cf896cb3d2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
ndc (product): 43063-929
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.99d7a84b-c755-47be-9d2d-1223162b0a422026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
ndc (product): 43063-930
IndomethacinINDOMETHACINBryant Ranch Prepackbf11f5a0-f2ee-499a-8d54-9d557cc668412026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINPreferred Pharmaceuticals Inc.1bb80a9f-def3-4228-ab04-a0c2a117a2b92026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINCoupler LLC51266787-b50e-bc15-e063-6394a90ad16f2026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINSt. Mary's Medical Park Pharmacy6312c9a6-d4d3-eb1f-e053-2991aa0a5e682026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
ndc (product): 60760-294
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.b4cf01d1-0d71-4f0f-97a5-07a59744149f2026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
ndc (product): 43063-368
IndomethacinINDOMETHACINREMEDYREPACK INC.16238287-d4b0-4afa-8483-1f4ae250a6252026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINRedPharm Drug, Inc.4d9ef14a-4812-4fcf-e054-00144ff8d46c2026-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
ndc (product): 67296-0886
IndomethacinINDOMETHACINA-S Medication Solutions7755391e-ede3-4a32-854c-736dc6dd2ee32026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
ndc (product): 50090-2987
ndc (product): 50090-0054
IndomethacinINDOMETHACINA-S Medication Solutions927af761-2f37-4e81-a86e-d4fb17cc18972026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
ndc (product): 50090-2803
IndomethacinINDOMETHACINNorthwind Health Company, LLCc9f4eda2-5c8f-72eb-e053-2a95a90a06be2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
ndc (product): 51655-329
IndomethacinINDOMETHACINNorthwind Health Company, LLCdb0f1127-ebd8-636c-e053-2a95a90a4d442026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINGlenmark Pharmaceuticals Inc., USAf7ed39e2-5431-4e47-935c-c7441d058f942025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
ndc (product): 68462-302
IndomethacinINDOMETHACINA-S Medication Solutions175a2d81-0d0f-46a3-aaaa-1732982d85fd2024-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
ndc (product): 50090-0055
IndomethacinINDOMETHACINBryant Ranch Prepack9ce37860-407f-47c7-a64c-62b6cc7292982024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINNuCare Pharmaceuticals, Inc.503455d9-471e-554f-e054-00144ff88e882024-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
ndc (product): 68071-3277
INDOMETHACININDOMETHACINDIRECT RX4d9a253a-f014-4fab-e054-00144ff8d46c2024-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
ndc (product): 61919-164
ndc (product): 61919-526
IndomethacinINDOMETHACINProficient Rx LP86c94559-b453-4e61-a76c-6962872f06552022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
ndc (product): 63187-948

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