MedPath
FDA Product

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

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

Basic Information

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

61919-022

Regulatory Information

61919-022

ANDA089175

C73584

March 30, 2023

USA

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

HUMAN PRESCRIPTION DRUG LABEL

8

Company Information

DIRECT RX

079254320

Active Ingredients

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

CROSPOVIDONE

Code: 68401960MK

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

BUTALBITAL

Quantity: 50 mg in 1 1

Code: KHS0AZ4JVK

Class Code: ACTIB

CAFFEINE

Quantity: 40 mg in 1 1

Code: 3G6A5W338E

Class Code: ACTIB

ACETAMINOPHEN

Quantity: 325 mg in 1 1

Code: 362O9ITL9D

Class Code: ACTIB

Active Moieties

BUTALBITAL

Code: KHS0AZ4JVK

ACETAMINOPHEN

Code: 362O9ITL9D

CAFFEINE

Code: 3G6A5W338E

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