butalbital and acetaminophen

Product NDC: 51862-544
11-digit product format: 518620544
Labeler code: 51862
Product ID: 51862-544_ed0bd699-c248-60f4-e053-2995a90a781f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: butalbital and acetaminophen
Dosage form: CAPSULE
Route: ORAL
Labeler: Mayne Pharma
Application: ANDA207313
Marketing category: ANDA
Marketing start: 2018-07-30
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; BUTALBITAL
Active strength: 300 mg/1; mg/1
Pharmacologic classes: Barbiturate [EPC], Barbiturates [CS]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2023-12-31
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	51862-544		D	Discontinued by firm	2026-08-03
excluded package	package	51862-544	51862-544-01	D	Discontinued by firm	2026-08-03
excluded package	package	51862-544	51862-544-05	D	Discontinued by firm	2026-08-03

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 · 13 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	51862-544-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51862-544-05	`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	51862-544-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51862-544-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51862-544-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51862-544-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51862-544-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51862-544-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51862-544-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51862-544-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51862-544-05	`0efc9e666f02…`	`f202fb6c5f17…`

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
A207313-001	BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207313-001	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 · 41 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	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL		RS	2017-12-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL		RS	2017-12-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL		RS	2017-12-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207313-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	RS	2017-12-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207313-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207313-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207313-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207313-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207313-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207313-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207313-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207313-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207313-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207313-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207313-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207313-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207313-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207313-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207313-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207313-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207313-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207313-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207313-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207313-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207313-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207313-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207313-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207313-001	AA	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207313-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207313-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207313-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207313-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207313-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207313-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207313-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207313-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207313-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207313-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207313-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207313-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207313-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207313-001	AA	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-544-01	EA - Each	51862-544	f8ea45d7-b1b3-4246-822d-46d88680c61b	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51862-544	BUTALBITAL AND ACETAMINOPHEN CAPSULE [MAYNE PHARMA]	7	Legacy NDC	20250110_c45b797e-62b2-4944-989e-c17b4204ffdb.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	Dr. Reddy's Labratories Inc.	42d808d6-d8d4-22f5-ac2f-0f0d1d71686a	2024-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207313 application number: ANDA207313

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51862-544-01	51862054401	100 CAPSULE in 1 BOTTLE (51862-544-01)	100 capsule	2018-07-30	0000-00-00	No	No	Current
51862-544-05	51862054405	500 CAPSULE in 1 BOTTLE (51862-544-05)	500 capsule	2018-07-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
butalbital and acetaminophen - Mayne Pharma	Mayne Pharma	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	7