Butalbital, Acetaminophen and Caffeine

Product NDC: 64950-290
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 45.

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 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-11-14 07:37:17	2026-10	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`c2088c7a36db…`
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…`

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

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
756245	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
5f603b0d-69e5-4c02-b6b3-b4705e243e9a	Available on FDA.report

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

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