Application 040511

Type: ANDA
Sponsor: VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	TABLET;ORAL	325MG;50MG;40MG	No	Yes

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
A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	TABLET / ORAL			2003-08-27

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	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL			2003-08-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL			2003-08-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040511-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2003-08-27	`f41ea6bd6efb…`

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	A040511-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040511-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040511-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040511-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040511-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040511-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040511-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040511-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040511-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040511-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040511-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040511-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040511-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040511-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040511-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040511-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040511-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040511-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040511-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040511-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040511-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040511-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040511-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040511-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040511-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040511-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040511-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040511-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040511-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040511-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040511-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040511-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040511-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040511-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040511-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040511-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040511-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040511-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040511-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040511-001	AA	1	`cb3db0bc1861…`

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 2 · 37 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	Sun Pharmaceutical Industries, Inc.	a68de112-f5af-49ba-a8a8-3adbaa7df36e	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Butalbital, Acetaminophen and Caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Bryant Ranch Prepack	f6bd2076-869e-40de-94ce-6be43d50f680	2026-07-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Bryant Ranch Prepack	8a4cf981-37f7-4bc9-a9d7-b134a5fd0894	2026-07-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Preferred Pharmaceuticals Inc.	65fa9aca-ef3d-4bc6-a107-72e6eb5ce224	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Butalbital, Acetaminophen and Caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Amici Pharma, Inc.	fb12459c-82f8-43d2-8c05-a4b6d4a3e948	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Redpharm Drug	4727e806-102a-3a28-e063-6294a90ab6e9	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Butalbital, Acetaminophen and Caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Advanced Rx of Tennessee, LLC	45a18fad-ad4e-3a1b-e063-6394a90a23cf	2025-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Chartwell RX, LLC	77776146-c6e6-478c-b30e-2b729e758400	2025-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Genus Lifesciences Inc.	5f603b0d-69e5-4c02-b6b3-b4705e243e9a	2025-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Butalbital, Acetaminophen and Caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Bryant Ranch Prepack	2eefa0ac-70f6-43ab-b59e-c4ecad853fe7	2025-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ST. MARY'S MEDICAL PARK PHARMACY	36229f70-aa73-b112-e063-6394a90a5b49	2025-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Butalbital, Acetaminophen and Caffeine
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Aurolife Pharma, LLC	f9fde75d-7def-48fc-a2b0-727f677f6001	2025-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Butalbital, Acetaminophen and Caffeine
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	A-S Medication Solutions	21a148d1-b242-4414-82b2-cb78387d7d0f	2025-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Butalbital, Acetaminophen and Caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Bryant Ranch Prepack	03475828-eae2-49ed-a1c0-8074f35c712d	2025-03-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Advanced Rx of Tennessee, LLC	2e20e0ee-dd73-6287-e063-6294a90a03b1	2025-02-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Bryant Ranch Prepack	b9df47cf-f999-49d8-95b9-374c0539b6a1	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	SUNRISE PHARMACEUTICAL, INC	ee7630f8-f4b8-4eb0-b34d-d908567030c4	2025-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Bryant Ranch Prepack	3fe91e9f-4033-4b48-b51b-7eb67d40fa3a	2024-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Preferred Pharmaceuticals Inc.	91e50642-d278-47c6-944b-4ed907e87e6b	2024-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	SOLCO HEALTHCARE US, LLC	5c9c3407-212a-4ae9-a574-2b0c53f3c5eb	2024-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-2544	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Par Pharmaceutical, Inc.	ANDA	Current
0603-2544	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Par Pharmaceutical	ANDA	Current
0603-2544	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Par Pharmaceutical	ANDA	Current
55154-7147	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Cardinal Health 107, LLC	ANDA	Current
55154-7147	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Cardinal Health	ANDA	Current
55154-7147	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Cardinal Health	ANDA	Current
55289-879	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-879	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
60687-672	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	American Health Packaging	ANDA	Current
60687-672	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	American Health Packaging	ANDA	Current
63629-1774	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current
63629-2140	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current
63629-2140	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current
63629-2140	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current
63629-2140	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current
63629-2151	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current
63629-2151	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current
63629-2151	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current
63629-2151	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current
64380-157	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Strides Pharma Science Limited	ANDA	Current
64380-157	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Strides Pharma Science Limited	ANDA	Current
64380-157	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Strides Pharma Science Limited	ANDA	Current
64380-157	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Strides Pharma Science Limited	ANDA	Current
67296-0718	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen and Caffeine	RedPharm Drug Inc.	ANDA	Current
67544-394	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
68084-396	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	American Health Packaging	ANDA	Current
68084-396	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen and Caffeine	American Health Packaging	ANDA	Current
68084-396	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen and Caffeine	American Health Packaging	ANDA	Current
68084-396	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen and Caffeine	American Health Packaging	ANDA	Current
68084-396	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen and Caffeine	American Health Packaging	ANDA	Current
68151-1313	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Carilion Materials Management	ANDA	Current
71335-1977	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current
71335-1977	Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	Bryant Ranch Prepack	ANDA	Current