Finasteride

Product NDC: 42291-280
11-digit product format: 422910280
Labeler code: 42291
Product ID: 42291-280_6361db95-e3d1-4b99-e053-2991aa0a94fe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Finasteride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvKARE, Inc.
Application: ANDA076511
Marketing category: ANDA
Marketing start: 2013-02-26
Marketing end: 0000-00-00
Substance: FINASTERIDE
Active strength: 5 mg/1
Pharmacologic classes: 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42291-280		D	Discontinued by firm	2026-08-07
excluded package	package	42291-280	42291-280-50	D	Discontinued by firm	2026-08-07
excluded package	package	42291-280	42291-280-90	D	Discontinued by firm	2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42291-280-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42291-280-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42291-280-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42291-280-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42291-280-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42291-280-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42291-280-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42291-280-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42291-280-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42291-280-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42291-280-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42291-280-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42291-280-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42291-280-50	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42291-280-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42291-280-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42291-280-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42291-280-50	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42291-280-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42291-280-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42291-280-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42291-280-50	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42291-280-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42291-280-50	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076511-001	FINASTERIDE	FINASTERIDE	5MG	TABLET / ORAL	AB		2006-12-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076511-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076511-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2006-12-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076511-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076511-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076511-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076511-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076511-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076511-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076511-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076511-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076511-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076511-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076511-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076511-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076511-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076511-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076511-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076511-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076511-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076511-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076511-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076511-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076511-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076511-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076511-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076511-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076511-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076511-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076511-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076511-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076511-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076511-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076511-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076511-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076511-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076511-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076511-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076511-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076511-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076511-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076511-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076511-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-280-30	EA - Each	42291-280	cb043b08-1cea-4246-8eb0-61f0c08bd5dc	1	2013-05-02
42291-280-50	EA - Each	42291-280	11f2a863-0e0b-4c6e-b645-577bdc26279a	1	2013-05-02
42291-280-90	EA - Each	42291-280	90af7bc3-3f40-45fe-979b-90cd8640bcb7	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FINASTERIDE	ACTIVE INGREDIENT	57GNO57U7G	FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.]	5
FINASTERIDE	ACTIVE MOIETY	57GNO57U7G	FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.]	5
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.]	5
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.]	5
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.]	5
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.]	5
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.]	5

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Finasteride	FINASTERIDE	Teva Pharmaceuticals USA, Inc.	77589cc3-c440-4695-800c-82a0e5128a6c	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076511 application number: ANDA076511