Acebutolol Hydrochloride

Product NDC: 42291-101
11-digit product format: 422910101
Labeler code: 42291
Product ID: 42291-101_8f88d4ef-c3e6-ca53-e053-2995a90af77c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acebutolol Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: AvKARE, Inc.
Application: ANDA075047
Marketing category: ANDA
Marketing start: 2009-12-14
Marketing end: 0000-00-00
Substance: ACEBUTOLOL HYDROCHLORIDE
Active strength: 200 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42291-101		D	Discontinued by firm		2026-08-10
excluded package	package	42291-101	42291-101-90	D	Discontinued by firm		2026-08-10

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 · 24 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	42291-101-90	`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	42291-101-90	`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	42291-101-90	`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	42291-101-90	`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	42291-101-90	`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	42291-101-90	`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	42291-101-90	`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	42291-101-90	`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	42291-101-90	`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	42291-101-90	`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	42291-101-90	`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	42291-101-90	`557ba5c1ecfa…`	`9c80585c8c6e…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075047-001	ACEBUTOLOL HYDROCHLORIDE	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30
A075047-002	ACEBUTOLOL HYDROCHLORIDE	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075047-001	AB
A075047-002	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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		RS	1999-12-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL		RS	1999-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	A075047-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075047-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075047-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075047-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075047-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075047-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075047-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075047-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075047-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075047-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075047-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075047-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075047-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075047-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075047-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075047-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075047-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075047-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075047-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075047-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075047-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075047-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075047-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075047-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075047-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075047-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075047-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075047-002	AB	1	`8072bd15b7f6…`
2022-04-08 23:34 UTC	2022-04	A075047-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075047-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075047-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075047-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075047-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075047-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075047-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075047-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075047-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075047-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075047-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075047-002	AB	1	`87673890dc5c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-101-90	EA - Each	42291-101	26f9fce3-8c27-4f63-82a3-ce7985107a9c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACEBUTOLOL HYDROCHLORIDE	ACTIVE INGREDIENT	B025Y34C54	ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.]	8
ACEBUTOLOL	ACTIVE MOIETY	67P356D8GH	ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.]	8
D&c Red No. 28	INACTIVE INGREDIENT	767IP0Y5NH	ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.]	8
D&c Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.]	8
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.]	8
Fd&c Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.]	8
Gelatin	INACTIVE INGREDIENT	2G86QN327L	ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.]	8
Povidone	INACTIVE INGREDIENT	FZ989GH94E	ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.]	8
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.]	8
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.]	8
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE, INC.]	8

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acebutolol Hydrochloride	ACEBUTOLOL HYDROCHLORIDE	AvKARE	fa40a564-a579-15c1-e053-6294a90ad8e9	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075047 application number: ANDA075047
Acebutolol Hydrochloride	ACEBUTOLOL HYDROCHLORIDE	AvPAK	ff68a002-d46d-4f9f-0705-427844ea3655	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075047 application number: ANDA075047
Acebutolol Hydrochloride	ACEBUTOLOL HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	fe2cd5c0-ee16-4bcb-ad92-3755881dbe79	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075047 application number: ANDA075047
Acebutolol Hydrochloride	ACEBUTOLOL HYDROCHLORIDE	Amneal Pharmaceuticals LLC	28f8c26c-a1e1-4485-a45f-05c82f7a34b5	2024-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075047 application number: ANDA075047