Butalbital, Acetaminophen, Caffeine

Product NDC: 55700-920
11-digit product format: 557000920
Labeler code: 55700
Product ID: 55700-920_a433a5a4-6b7b-47e4-89ff-1b2d7fad638c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Butalbital, Acetaminophen, and Caffeine
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA209587
Marketing category: ANDA
Marketing start: 2021-07-29
Marketing end: 0000-00-00
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: 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	55700-920		D	Discontinued by firm	2026-08-17
excluded package	package	55700-920	55700-920-12	D	Discontinued by firm	2026-08-17
excluded package	package	55700-920	55700-920-30	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 · 21 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	55700-920-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-920-30	`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	55700-920-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55700-920-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55700-920-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55700-920-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55700-920-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55700-920-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55700-920-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55700-920-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55700-920-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55700-920-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55700-920-12	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-920-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-920-12	`0efc9e666f02…`	`f202fb6c5f17…`

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
A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA		2018-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209587-001	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	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209587-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-10-31	`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	A209587-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209587-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209587-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209587-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209587-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209587-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209587-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209587-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209587-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209587-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209587-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209587-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209587-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209587-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209587-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209587-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209587-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209587-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209587-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209587-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209587-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209587-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209587-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209587-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209587-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209587-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209587-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209587-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209587-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209587-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209587-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209587-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209587-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209587-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209587-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209587-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209587-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209587-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209587-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209587-001	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
55700-920-12	EA - Each	55700-920	bcb4d217-21c8-4709-ac32-1c58fa37ea70	1	2021-10-08
55700-920-30	EA - Each	55700-920	294e381b-ad3a-471a-adf0-1c3bf25637c3	1	2021-10-08

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	HAWAII REPACK, INC.	ab882f60-394c-4d4f-95f4-6b9d6d6b3193	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Preferred Pharmaceuticals Inc.	b121190e-db2a-43bb-a57d-b6683a9e2059	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Advanced Rx of Tennessee, LLC	4871c36f-229b-4c12-e063-6394a90a028e	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	REMEDYREPACK INC.	dc2bb7fc-1722-4865-a02c-be5e5c211505	2026-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Asclemed USA, Inc.	cce09e09-158f-4927-8a3e-4ec9334f0b7a	2025-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
BUTAL/APAP/CAFFEINE	BUTAL/APAP/CAFFEINE	Direct_Rx	2abb9915-edb2-6218-e063-6394a90ad462	2025-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	AvPAK	e5fbd6b8-85e7-8847-e053-2a95a90a52ed	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Proficient Rx LP	3cf799b4-c785-4ae2-908b-c42e426733dc	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Bryant Ranch Prepack	e2978345-826a-47d2-acf3-feb6afb1967e	2024-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, and Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	LGM PHARMA SOLUTIONS, LLC	f6548126-faa1-4f53-8e0b-bc1b743de04d	2024-02-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	A-S Medication Solutions	f822c103-b678-4e76-8174-33b94421dd1e	2024-02-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Proficient Rx LP	d860af16-fab4-4263-9e66-a648d5e81dab	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Bryant Ranch Prepack	90e166ac-8789-4e7a-b5bb-37c475e3a5b0	2023-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587
Butalbital, Acetaminophen, Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Westminster Pharmaceuticals, LLC	1c0511d0-fe63-45c6-8da2-6ceeb56edb17	2019-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209587 application number: ANDA209587

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	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-920-12	55700092012	12 TABLET, COATED in 1 BOTTLE (55700-920-12)	2021-09-10	0000-00-00	No	No	Current
55700-920-30	55700092030	30 TABLET, COATED in 1 BOTTLE (55700-920-30)	2021-07-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg	Quality Care Products, LLC	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	4