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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-03-09 01:35 UTC2022-03A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22782e0a99824c…
2021-12-28 21:50 UTC2021-12A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2022-03-09 01:35 UTC2022-03A091276-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091276-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091276-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091276-002AB1782e0a99824c…

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 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
ndc (product): 70518-1512
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.009097a5-2c1e-4f5d-8054-896cf896cb3d2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.99d7a84b-c755-47be-9d2d-1223162b0a422026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINBryant Ranch Prepackbf11f5a0-f2ee-499a-8d54-9d557cc668412026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
ndc (product): 71335-0355
IndomethacinINDOMETHACINPreferred Pharmaceuticals Inc.1bb80a9f-def3-4228-ab04-a0c2a117a2b92026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
ndc (product): 68788-6448
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
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.b4cf01d1-0d71-4f0f-97a5-07a59744149f2026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINREMEDYREPACK INC.16238287-d4b0-4afa-8483-1f4ae250a6252026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
ndc (product): 70518-1458
IndomethacinINDOMETHACINRedPharm Drug, Inc.4d9ef14a-4812-4fcf-e054-00144ff8d46c2026-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINA-S Medication Solutions7755391e-ede3-4a32-854c-736dc6dd2ee32026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINA-S Medication Solutions927af761-2f37-4e81-a86e-d4fb17cc18972026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINNorthwind Health Company, LLCc9f4eda2-5c8f-72eb-e053-2a95a90a06be2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
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): 68462-406
IndomethacinINDOMETHACINA-S Medication Solutions175a2d81-0d0f-46a3-aaaa-1732982d85fd2024-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINBryant Ranch Prepack9ce37860-407f-47c7-a64c-62b6cc7292982024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
ndc (product): 71335-0107
IndomethacinINDOMETHACINNuCare Pharmaceuticals, Inc.503455d9-471e-554f-e054-00144ff88e882024-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
INDOMETHACININDOMETHACINDIRECT RX4d9a253a-f014-4fab-e054-00144ff8d46c2024-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINProficient Rx LP86c94559-b453-4e61-a76c-6962872f06552022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68462-406IndomethacinIndomethacinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-406IndomethacinIndomethacinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-406IndomethacinIndomethacinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-406IndomethacinIndomethacinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-406IndomethacinIndomethacinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-406IndomethacinIndomethacinGlenmark Pharmaceuticals Inc., USAANDACurrent
68788-6448IndomethacinIndomethacinPreferred Pharmaceuticals Inc.ANDACurrent
68788-6448IndomethacinIndomethacinPreferred Pharmaceuticals Inc.ANDACurrent
68788-6448IndomethacinIndomethacinPreferred Pharmaceuticals Inc.ANDACurrent
68788-6448IndomethacinIndomethacinPreferred Pharmaceuticals Inc.ANDACurrent
68788-6448IndomethacinIndomethacinPreferred Pharmaceuticals Inc.ANDACurrent
68788-6983IndomethacinIndomethacinPreferred Pharmaceuticals Inc.ANDACurrent
68788-6983IndomethacinIndomethacinPreferred Pharmaceuticals Inc.ANDACurrent
68788-6983IndomethacinIndomethacinPreferred Pharmaceuticals Inc.ANDACurrent
68788-6983IndomethacinIndomethacinPreferred Pharmaceuticals Inc.ANDACurrent
68788-6983IndomethacinIndomethacinPreferred Pharmaceuticals Inc.ANDACurrent
70518-0254IndomethacinIndomethacinREMEDYREPACK INC.ANDACurrent
70518-0254IndomethacinIndomethacinREMEDYREPACK INC.ANDACurrent
70518-0254IndomethacinIndomethacinREMEDYREPACK INC.ANDACurrent
70518-0254IndomethacinIndomethacinREMEDYREPACK INC.ANDACurrent
70518-0254IndomethacinIndomethacinREMEDYREPACK INC.ANDACurrent
70518-0254IndomethacinIndomethacinREMEDYREPACK INC.ANDACurrent
70518-1458IndomethacinIndomethacinREMEDYREPACK INC.ANDACurrent
70518-1458IndomethacinIndomethacinREMEDYREPACK INC.ANDACurrent
70518-1458IndomethacinIndomethacinREMEDYREPACK INC.ANDACurrent
70518-1458IndomethacinIndomethacinREMEDYREPACK INC.ANDACurrent
70518-1458IndomethacinIndomethacinREMEDYREPACK INC.ANDACurrent
70518-1512IndomethacinIndomethacinREMEDYREPACK INC.ANDACurrent
70518-1512IndomethacinIndomethacinREMEDYREPACK INC.ANDACurrent
70518-1512IndomethacinIndomethacinREMEDYREPACK INC.ANDACurrent
70518-1512IndomethacinIndomethacinREMEDYREPACK INC.ANDACurrent
70518-1512IndomethacinIndomethacinREMEDYREPACK INC.ANDACurrent
70518-1512IndomethacinIndomethacinREMEDYREPACK INC.ANDACurrent
70518-1512IndomethacinIndomethacinREMEDYREPACK INC.ANDACurrent
70518-1512IndomethacinIndomethacinREMEDYREPACK INC.ANDACurrent
70934-181IndomethacinIndomethacinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-181IndomethacinIndomethacinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-181IndomethacinIndomethacinDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-395IndomethacinIndomethacinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-395IndomethacinIndomethacinDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-395IndomethacinIndomethacinDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-527IndomethacinIndomethacinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-159IndomethacinIndomethacinProficient Rx LPANDACurrent
71205-159IndomethacinIndomethacinProficient Rx LPANDACurrent
71205-159IndomethacinIndomethacinProficient Rx LPANDACurrent
71205-159IndomethacinIndomethacinProficient Rx LPANDACurrent
71335-0107IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
71335-0107IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
71335-0107IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
71335-0355IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
71335-0355IndomethacinIndomethacinBryant Ranch PrepackANDACurrent
71335-0355IndomethacinIndomethacinBryant Ranch PrepackANDACurrent