MedPath
FDA Product

Butalbital, Acetaminophen and Caffeine

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Butalbital, Acetaminophen and Caffeine

64380-157

Regulatory Information

64380-157

ANDA040511

C73584

July 27, 2022

USA

Butalbital, Acetaminophen and Caffeine Tablets, USP CIII50 mg/325 mg/40 mg

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

650738743

Active Ingredients

BUTALBITAL

Quantity: 50 mg in 1 1

Code: KHS0AZ4JVK

Class Code: ACTIB

ACETAMINOPHEN

Quantity: 325 mg in 1 1

Code: 362O9ITL9D

Class Code: ACTIB

CAFFEINE

Quantity: 40 mg in 1 1

Code: 3G6A5W338E

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

Active Moieties

BUTALBITAL

Code: KHS0AZ4JVK

ACETAMINOPHEN

Code: 362O9ITL9D

CAFFEINE

Code: 3G6A5W338E

© Copyright 2025. All Rights Reserved by MedPath