BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product NDC: 51407-200
Requested package NDC: 51407-200-01
11-digit product format: 514070200
Labeler code: 51407
Product ID: 51407-200_a2dfbeda-9b7b-064f-e053-2995a90a9250
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: butalbital, acetaminophen and caffeine
Dosage form: CAPSULE
Route: ORAL
Labeler: Golden State Medical Supply
Application: ANDA207118
Marketing category: ANDA
Marketing start: 2016-10-28
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; CAFFEINE; BUTALBITAL
Active strength: 300 mg/1; mg/1; mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],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	51407-200	51407-200-01	D	Discontinued by firm		2026-08-11

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 · 12 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…`

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
A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA		2016-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207118-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207118-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2016-10-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A207118-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207118-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207118-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207118-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207118-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207118-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207118-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207118-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207118-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207118-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207118-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207118-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207118-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207118-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207118-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207118-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207118-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207118-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207118-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207118-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207118-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207118-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207118-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207118-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207118-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207118-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207118-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207118-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207118-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207118-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207118-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207118-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207118-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207118-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207118-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207118-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207118-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207118-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207118-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207118-001	AA	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-200-01	EA - Each	51407-200	ee9e5fe4-d409-49b4-b95b-90c5daa718ea	1	2019-07-02

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	Bryant Ranch Prepack	03475828-eae2-49ed-a1c0-8074f35c712d	2025-03-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207118 application number: ANDA207118
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	SUNRISE PHARMACEUTICAL, INC	ee7630f8-f4b8-4eb0-b34d-d908567030c4	2025-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207118 application number: ANDA207118
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Bryant Ranch Prepack	3fe91e9f-4033-4b48-b51b-7eb67d40fa3a	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207118 application number: ANDA207118

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE
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
51407-200-01	51407020001	100 CAPSULE in 1 BOTTLE (51407-200-01)	100 capsule	2019-02-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Butalbital, Acetaminophen and Caffeine Capsules, USP	Golden State Medical Supply	2020-04-21	HUMAN PRESCRIPTION DRUG LABEL	2