Butalbital, Acetaminophen and Caffeine

Basic Information

Product Name

FDA Product Code

68071-2927

Regulatory Information

NDC Product Code

68071-2927

Application Number

ANDA040864

Marketing Category

C73584

Effective Date

February 3, 2023

Territorial Authority

USA

FDA Title

Butalbital, Acetaminophen and Caffeine Tablets, USP 50 mg/325 mg/40 mg, Clll Rx only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

BUTALBITAL

Quantity: 50 mg in 1 1

Code: KHS0AZ4JVK

Class Code: ACTIB

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

ACETAMINOPHEN

Quantity: 325 mg in 1 1

Code: 362O9ITL9D

Class Code: ACTIB

CAFFEINE

Quantity: 40 mg in 1 1

Code: 3G6A5W338E

Class Code: ACTIB

Active Moieties

CAFFEINE

Code: 3G6A5W338E

ACETAMINOPHEN

Code: 362O9ITL9D

BUTALBITAL

Code: KHS0AZ4JVK

Basic Information

Regulatory Information

Company Information

Active Ingredients

SODIUM STARCH GLYCOLATE TYPE A POTATO

MAGNESIUM STEARATE

CELLULOSE, MICROCRYSTALLINE

Active Moieties

CAFFEINE

ACETAMINOPHEN

BUTALBITAL