Acebutolol Hydrochloride

Product NDC: 42291-010
Requested package NDC: 42291-010-01
11-digit product format: 422910010
Labeler code: 42291
Product ID: 42291-010_48481cfc-a410-bc0a-e063-6294a90a7baf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acebutolol Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: AvKARE
Application: ANDA075047
Marketing category: ANDA
Marketing start: 2023-04-26
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075047-001	ACEBUTOLOL HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075047-002	ACEBUTOLOL HYDROCHLORIDE	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	1999-12-30	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075047-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075047-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075047-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075047-002	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Acebutolol Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACEBUTOLOL HYDROCHLORIDE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
B025Y34C54	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
998689	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fa40a564-a579-15c1-e053-6294a90ad8e9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b2b9ebc1-3e2b-b877-2cfb-b7c92cf3c5fa	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42291-010-01	Acebutolol Hydrochloride	100 in 1 BOTTLE	CAPSULE	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-010-01	EA - Each	42291-010	f9355d4a-c2ed-4f57-9a38-2e3d144eabf4	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-010	ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVKARE]	1	Current NDC, 1 package rows	20230427_fa40a564-a579-15c1-e053-6294a90ad8e9.zip

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 ndc (package): 42291-010-01 ndc (product): 42291-010 ndc11 (package): 42291001001
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
B025Y34C54	ACEBUTOLOL HYDROCHLORIDE	34381-68-5	ACEBUTOLOL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
998689	acebutolol HCl 200 MG Oral Capsule	PSN	fa40a564-a579-15c1-e053-6294a90ad8e9	2
998689	acebutolol 200 MG Oral Capsule	SCD	fa40a564-a579-15c1-e053-6294a90ad8e9	2
998689	acebutolol (as acebutolol HCl) 200 MG Oral Capsule	SY	fa40a564-a579-15c1-e053-6294a90ad8e9	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42291-010-01	42291001001	100 CAPSULE in 1 BOTTLE (42291-010-01)	100 capsule	2023-04-26	No	No	Current