Butalbital and Acetaminophen

Product NDC: 79739-7075
Requested package NDC: 79739-7075-1
11-digit product format: 797397075
Labeler code: 79739
Product ID: 79739-7075_a24ccca7-e347-44e4-b700-1cc54c525bd3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Butalbital and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: LGM Pharma Solutions, LLC
Application: ANDA090956
Marketing category: ANDA
Marketing start: 2011-08-23
Marketing end: 0000-00-00
Substance: BUTALBITAL; ACETAMINOPHEN
Active strength: 50 mg/1; mg/1
Pharmacologic classes: Barbiturates [CS],Barbiturate [EPC]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	79739-7075	79739-7075-1	I	Inactivated by FDA		2026-09-14

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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

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
A090956-001	BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090956-001	AA

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 · 43 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	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090956-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	TABLET / ORAL	AA	RS	2011-08-23	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A090956-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090956-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090956-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090956-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090956-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090956-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090956-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090956-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090956-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090956-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090956-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090956-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090956-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090956-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090956-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090956-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090956-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090956-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090956-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090956-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090956-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090956-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090956-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090956-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090956-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090956-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090956-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090956-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090956-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090956-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090956-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090956-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090956-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090956-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090956-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090956-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090956-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090956-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090956-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090956-001	AA	1	`f41ea6bd6efb…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
79739-7075-1	2022-01-28	C162847	48780-1	d6a99b39-c784-a426-e053-dadaa90af4c2	Butalbital and Acetaminophen Tablets 50 mg/300 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79739-7075-1	Butalbital and Acetaminophen	100 in 1 BOTTLE, PLASTIC	TABLET	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79739-7075	BUTALBITAL AND ACETAMINOPHEN TABLET [LGM PHARMA SOLUTIONS, LLC]	1	Legacy NDC, 1 package rows	20200814_a24ccca7-e347-44e4-b700-1cc54c525bd3.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Butalbital and Acetaminophen	BUTALBITAL AND ACETAMINOPHEN TABLETS	Oceanside Pharmaceuticals	d2213ffd-18f6-45f5-9af7-690a977562c4	2020-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090956 application number: ANDA090956

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KHS0AZ4JVK	BUTALBITAL	77-26-9	BUTALBITAL
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1249617	butalbital 50 MG / acetaminophen 300 MG Oral Tablet	PSN	a24ccca7-e347-44e4-b700-1cc54c525bd3	1
1249617	acetaminophen 300 MG / butalbital 50 MG Oral Tablet	SCD	a24ccca7-e347-44e4-b700-1cc54c525bd3	1
1249617	APAP 300 MG / butalbital 50 MG Oral Tablet	SY	a24ccca7-e347-44e4-b700-1cc54c525bd3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79739-7075-1	79739707501	100 TABLET in 1 BOTTLE, PLASTIC (79739-7075-1)	100 tablet	2011-08-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Butalbital and Acetaminophen Tablets 50 mg/300 mg	LGM Pharma Solutions, LLC	2020-08-13	HUMAN PRESCRIPTION DRUG LABEL	1