butalbital, acetaminophen and caffeine

Product NDC: 51862-540
Requested package NDC: 51862-540-05
11-digit product format: 518620540
Labeler code: 51862
Product ID: 51862-540_ea23805b-70aa-2efd-e053-2995a90a43af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: butalbital, acetaminophen and caffeine
Dosage form: TABLET
Route: ORAL
Labeler: Mayne Pharma
Application: ANDA089175
Marketing category: ANDA
Marketing start: 2015-08-28
Marketing end: 2025-03-31
Substance: ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength: 325 mg/1; mg/1; mg/1
Pharmacologic classes: Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 0000-00-00
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	51862-540	51862-540-05	D	Discontinued by firm		2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51862-540	51862-540-05	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51862-540	51862-540-05	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		1987-01-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089175-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089175-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	1987-01-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A089175-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089175-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089175-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089175-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089175-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089175-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089175-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089175-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089175-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089175-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089175-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089175-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089175-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089175-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089175-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089175-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089175-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089175-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089175-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089175-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089175-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089175-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089175-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089175-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089175-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089175-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089175-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089175-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089175-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089175-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089175-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089175-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089175-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089175-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089175-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089175-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089175-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089175-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089175-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089175-001	AA	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-540-01	EA - Each	51862-540	25b1b8f6-67da-4ca8-aad8-50ce53ecfa2e	1	2015-11-12
51862-540-05	EA - Each	51862-540	9d2657b1-aca8-4be9-979b-7bf40cf5547e	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MAYNE PHARMA]	1
BUTALBITAL	ACTIVE INGREDIENT	KHS0AZ4JVK	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MAYNE PHARMA]	1
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MAYNE PHARMA]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MAYNE PHARMA]	1
BUTALBITAL	ACTIVE MOIETY	KHS0AZ4JVK	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MAYNE PHARMA]	1
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MAYNE PHARMA]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MAYNE PHARMA]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MAYNE PHARMA]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MAYNE PHARMA]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MAYNE PHARMA]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MAYNE PHARMA]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MAYNE PHARMA]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MAYNE PHARMA]	1

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Chartwell RX, LLC	77776146-c6e6-478c-b30e-2b729e758400	2025-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089175 application number: ANDA089175
butalbital, acetaminophen and caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Mikart, LLC	a26775c2-cafb-4b13-99ac-d4e8248265fb	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089175 application number: ANDA089175
butalbital, acetaminophen and caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Proficient Rx LP	1bde13a5-cdd4-4bc2-8aeb-32e4dc157293	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089175 application number: ANDA089175

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
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51862-540-05	51862054005	500 TABLET in 1 BOTTLE, PLASTIC (51862-540-05)	500 tablet	2015-08-28	2025-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Butalbital/Acetaminophen/Caffeine Tablets.	Golden State Medical Supply, Inc.	2023-08-15	HUMAN PRESCRIPTION DRUG LABEL	7
butalbital, acetaminophen and caffeine - Mayne Pharma	Mayne Pharma	2022-10-03	HUMAN PRESCRIPTION DRUG LABEL	8
butalbital, acetaminophen and caffeine - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2021-02-17	HUMAN PRESCRIPTION DRUG LABEL	3