Butalbital, Acetaminophen and Caffeine

Product NDC: 64950-290
Requested package NDC: 64950-290-16
11-digit product format: 649500290
Labeler code: 64950
Product ID: 64950-290_7204a4c7-872e-4cf6-84e7-afcd2b1b26b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Butalbital, Acetaminophen, and Caffeine
Dosage form: SOLUTION
Route: ORAL
Labeler: Genus Lifesciences Inc.
Application: ANDA040387
Marketing category: ANDA
Marketing start: 2025-07-01
Substance: BUTALBITAL; ACETAMINOPHEN; CAFFEINE
Active strength: 50; 325; 40 mg/15mL; mg/15mL; mg/15mL
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: 2027-12-31
Current FDA listing: 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
A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL		RS	2003-01-31

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

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	50 mg/15mL
ACETAMINOPHEN	325 mg/15mL
CAFFEINE	40 mg/15mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64950-290-16	Butalbital, Acetaminophen and Caffeine	473 mL in 1 BOTTLE	SOLUTION	473		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64950-290-16	ML - Milliliter	64950-290	39be0e3d-51c9-424e-b62a-dff5d35922e1	1	2025-09-12

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 · 1 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	Genus Lifesciences Inc.	5f603b0d-69e5-4c02-b6b3-b4705e243e9a	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040387 application number: ANDA040387 ndc (package): 64950-290-16 ndc (product): 64950-290 ndc11 (package): 64950029016

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
756245	butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG in 15 mL Oral Solution	PSN	5f603b0d-69e5-4c02-b6b3-b4705e243e9a	2
756245	acetaminophen 21.7 MG/ML / butalbital 3.33 MG/ML / caffeine 2.67 MG/ML Oral Solution	SCD	5f603b0d-69e5-4c02-b6b3-b4705e243e9a	2
756245	acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG per 15 ML Elixir	SY	5f603b0d-69e5-4c02-b6b3-b4705e243e9a	2
756245	acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG per 15 ML Syrup	SY	5f603b0d-69e5-4c02-b6b3-b4705e243e9a	2
756245	APAP 21.7 MG/ML / butalbital 3.33 MG/ML / Caffeine 2.67 MG/ML Oral Solution	SY	5f603b0d-69e5-4c02-b6b3-b4705e243e9a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
64950-290-16	64950029016	473 mL in 1 BOTTLE (64950-290-16)	473 ml	2025-07-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Butalbital, Acetaminophen and Caffeine Oral Solution	Genus Lifesciences Inc.	2026-09-25	HUMAN PRESCRIPTION DRUG LABEL	3