Butalbital, Acetaminophen and Caffeine

Product NDC: 68788-4126
11-digit product format: 687884126
Labeler code: 68788
Product ID: 68788-4126_65fa9aca-ef3d-4bc6-a107-72e6eb5ce224
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Butalbital, Acetaminophen and Caffeine
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA211106
Marketing category: ANDA
Marketing start: 2026-06-09
Substance: BUTALBITAL; ACETAMINOPHEN; CAFFEINE
Active strength: 325 mg/1; 50 mg/1; 40 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
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	RS	2018-09-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211106-001	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	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211106-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG;50MG;40MG	TABLET / ORAL	AA	2018-09-26	`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	A211106-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211106-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211106-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211106-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211106-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211106-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211106-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211106-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211106-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211106-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211106-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211106-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211106-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211106-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211106-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211106-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211106-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211106-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211106-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211106-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211106-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211106-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211106-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211106-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211106-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211106-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211106-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211106-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211106-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211106-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211106-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211106-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211106-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211106-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211106-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211106-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211106-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211106-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211106-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211106-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Butalbital, Acetaminophen and Caffeine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUTALBITAL	325 mg/1
ACETAMINOPHEN	50 mg/1
CAFFEINE	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
KHS0AZ4JVK	Internal UNII lookup
362O9ITL9D	Internal UNII lookup
3G6A5W338E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
238154	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
65fa9aca-ef3d-4bc6-a107-72e6eb5ce224	Available on FDA.report

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 · 5 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	Preferred Pharmaceuticals Inc.	65fa9aca-ef3d-4bc6-a107-72e6eb5ce224	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211106 application number: ANDA211106 ndc (product): 68788-4126
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Redpharm Drug	4727e806-102a-3a28-e063-6294a90ab6e9	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211106 application number: ANDA211106
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	Exact identifier application applno (ANDA): 211106 application number: ANDA211106
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Bryant Ranch Prepack	e9dffed5-d615-4e63-9860-c0f6f23848a1	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211106 application number: ANDA211106
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	KVK-Tech, Inc.	7f9c4668-4f4a-453b-b2fa-a6fed903ddfa	2024-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211106 application number: ANDA211106

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KHS0AZ4JVK	BUTALBITAL	77-26-9	BUTALBITAL
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Status
68788-4126-2	68788412602	20 TABLET in 1 BOTTLE (68788-4126-2)	20 tablet	2026-06-09	0	Current
68788-4126-3	68788412603	30 TABLET in 1 BOTTLE (68788-4126-3)	30 tablet	2026-06-09	0	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Butalbital, Acetaminophen and Caffeine Tablets, USP 50 mg/325 mg/40 mg Rx Only	Preferred Pharmaceuticals Inc.	2026-06-09	HUMAN PRESCRIPTION DRUG LABEL	1