FDA.reportPublic FDA data

Butalbital, Acetaminophen and Caffeine

Product NDC
64950-290
11-digit product format
649500290
Labeler code
64950
Product ID
64950-290_791945e1-c3fd-491b-9593-292a6d07bdb6
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
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength
325; 50; 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Butalbital, Acetaminophen and Caffeine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/15mL
BUTALBITAL50 mg/15mL
CAFFEINE40 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E
Rxcui756245

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64950-290-16Butalbital, Acetaminophen and Caffeine473 mL in 1 BOTTLESOLUTION4732

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
756245butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG in 15 mL Oral SolutionPSN5f603b0d-69e5-4c02-b6b3-b4705e243e9a2
756245acetaminophen 21.7 MG/ML / butalbital 3.33 MG/ML / caffeine 2.67 MG/ML Oral SolutionSCD5f603b0d-69e5-4c02-b6b3-b4705e243e9a2
756245acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG per 15 ML ElixirSY5f603b0d-69e5-4c02-b6b3-b4705e243e9a2
756245acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG per 15 ML SyrupSY5f603b0d-69e5-4c02-b6b3-b4705e243e9a2
756245APAP 21.7 MG/ML / butalbital 3.33 MG/ML / Caffeine 2.67 MG/ML Oral SolutionSY5f603b0d-69e5-4c02-b6b3-b4705e243e9a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64950-290-1664950029016473 mL in 1 BOTTLE (64950-290-16) 473 ml2025-07-01NoNoCurrent