Application 091240

Type: ANDA
Sponsor: HETERO LABS LTD III

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INDOMETHACIN	INDOMETHACIN	CAPSULE;ORAL	25MG	No	No
002	INDOMETHACIN	INDOMETHACIN	CAPSULE;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091240-001	INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2011-04-12
A091240-002	INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE / ORAL	AB		2011-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091240-001	AB
A091240-002	AB

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A091240-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091240-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091240-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091240-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091240-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091240-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091240-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091240-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091240-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091240-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091240-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091240-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091240-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091240-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091240-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091240-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091240-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091240-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091240-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091240-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091240-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091240-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091240-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091240-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091240-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091240-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091240-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091240-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091240-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091240-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091240-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091240-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091240-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091240-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091240-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091240-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091240-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091240-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091240-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091240-002	AB	1	`4b0b4de00fa7…`

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 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indomethacin	INDOMETHACIN	XLCare Pharmaceuticals Inc.	bc8a572d-e0e1-4d37-b3c4-b85415d50393	2023-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240 ndc (product): 72865-148 ndc (product): 72865-149
Indomethacin	INDOMETHACIN	Proficient Rx LP	66e3205b-eab1-4864-bf36-116e9d79fe3e	2023-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Asclemed USA, Inc.	9c15102c-b6f9-4198-b592-152160591014	2022-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240 ndc (product): 76420-148
Indomethacin	INDOMETHACIN	Proficient Rx LP	8aa48212-19b0-4304-9c61-dcf4db2b19ea	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240 ndc (product): 71205-215

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 2 of 2 · 116 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66267-120	Indomethacin	Indomethacin	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-120	Indomethacin	Indomethacin	NuCare Pharmaceuticals, Inc.	ANDA	Current
67296-0954	Indomethacin	Indomethacin	RedPharm Drug, Inc.	ANDA	Current
67296-0954	Indomethacin	Indomethacin	RedPharm Drug, Inc.	ANDA	Current
67296-1525	Indomethacin	Indomethacin	RedPharm Drug, Inc.	ANDA	Current
67296-1525	Indomethacin	Indomethacin	RedPharm Drug, Inc.	ANDA	Current
67296-1525	Indomethacin	Indomethacin	RedPharm Drug, Inc.	ANDA	Current
68788-6821	Indomethacin	Indomethacin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6821	Indomethacin	Indomethacin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7362	Indomethacin	Indomethacin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7362	Indomethacin	Indomethacin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-8092	Indomethacin	Indomethacin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-8092	Indomethacin	Indomethacin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-8117	Indomethacin	Indomethacin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-8117	Indomethacin	Indomethacin	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2123	Indomethacin	Indomethacin	REMEDYREPACK INC.	ANDA	Current
70518-3324	Indomethacin	Indomethacin	REMEDYREPACK INC.	ANDA	Current
70518-3324	Indomethacin	Indomethacin	REMEDYREPACK INC.	ANDA	Current
70934-279	Indomethacin	Indomethacin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-279	Indomethacin	Indomethacin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-215	Indomethacin	Indomethacin	Proficient Rx LP	ANDA	Current
71205-215	Indomethacin	Indomethacin	Proficient Rx LP	ANDA	Current
71205-215	Indomethacin	Indomethacin	Proficient Rx LP	ANDA	Current
71205-215	Indomethacin	Indomethacin	Proficient Rx LP	ANDA	Current
71205-215	Indomethacin	Indomethacin	Proficient Rx LP	ANDA	Current
71335-0747	Indomethacin	Indomethacin	Bryant Ranch Prepack	ANDA	Current
71335-0747	Indomethacin	Indomethacin	Bryant Ranch Prepack	ANDA	Current
71335-0992	Indomethacin	Indomethacin	Bryant Ranch Prepack	ANDA	Current
71335-0992	Indomethacin	Indomethacin	Bryant Ranch Prepack	ANDA	Current
71335-0992	Indomethacin	Indomethacin	Bryant Ranch Prepack	ANDA	Current
71335-1250	Indomethacin	Indomethacin	Bryant Ranch Prepack	ANDA	Current
71335-1250	Indomethacin	Indomethacin	Bryant Ranch Prepack	ANDA	Current
71335-1568	Indomethacin	Indomethacin	Bryant Ranch Prepack	ANDA	Current
72865-148	Indomethacin	Indomethacin	XLCare Pharmaceuticals Inc.	ANDA	Current
72865-149	Indomethacin	Indomethacin	XLCare Pharmaceuticals Inc.	ANDA	Current
76420-148	Indomethacin	Indomethacin	Asclemed USA, Inc.	ANDA	Current