Acebutolol Hydrochloride

Product NDC: 10135-631
11-digit product format: 101350631
Labeler code: 10135
Product ID: 10135-631_cbe8fc7a-1138-07d3-e053-2995a90ab572
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acebutolol Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
Application: ANDA075047
Marketing category: ANDA
Marketing start: 2017-10-20
Marketing end: 0000-00-00
Substance: ACEBUTOLOL HYDROCHLORIDE
Active strength: 400 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	10135-631		I	Inactivated by FDA		2026-08-10
excluded package	package	10135-631	10135-631-01	I	Inactivated by FDA		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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10135-631-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10135-631-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10135-631-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10135-631-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10135-631-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10135-631-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10135-631-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10135-631-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10135-631-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10135-631-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10135-631-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10135-631-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-631-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-631-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-631-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	10135-631-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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 Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10135-631-01	2023-01-30	C162847	48780-1	f386c64a-22ad-0266-e053-dadaa90a7c1a	Acebutolol Hydrochloride Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10135-631-01	Acebutolol Hydrochloride	100 in 1 BOTTLE	CAPSULE	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-631-01	EA - Each	10135-631	739400fa-46fe-4191-aba4-53ea5f401cf2	1	2018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-631	ACEBUTOLOL HYDROCHLORIDE CAPSULE [MARLEX PHARMACEUTICALS INC]	6	Legacy NDC, 1 package rows	20210915_1620c4d3-6a6e-49be-b002-8e4358b0c7d6.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
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	1620c4d3-6a6e-49be-b002-8e4358b0c7d6	6
998685	acebutolol HCl 400 MG Oral Capsule	PSN	1620c4d3-6a6e-49be-b002-8e4358b0c7d6	6
998689	acebutolol 200 MG Oral Capsule	SCD	1620c4d3-6a6e-49be-b002-8e4358b0c7d6	6
998685	acebutolol 400 MG Oral Capsule	SCD	1620c4d3-6a6e-49be-b002-8e4358b0c7d6	6
998689	acebutolol (as acebutolol HCl) 200 MG Oral Capsule	SY	1620c4d3-6a6e-49be-b002-8e4358b0c7d6	6
998685	acebutolol (as acebutolol HCl) 400 MG Oral Capsule	SY	1620c4d3-6a6e-49be-b002-8e4358b0c7d6	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10135-631-01	10135063101	100 CAPSULE in 1 BOTTLE (10135-631-01)	100 capsule	2017-10-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acebutolol Hydrochloride Capsules	Marlex Pharmaceuticals Inc	2021-09-13	HUMAN PRESCRIPTION DRUG LABEL	6