Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate

Basic Information

Product Name

FDA Product Code

0591-2641

Regulatory Information

NDC Product Code

0591-2641

Application Number

ANDA076560

Marketing Category

C73584

Effective Date

March 31, 2021

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

CODEINE PHOSPHATE

Quantity: 30 mg in 1 1

Code: GSL05Y1MN6

Class Code: ACTIB

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: 300 mg in 1 1

Code: 362O9ITL9D

Class Code: ACTIB

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

BUTALBITAL

Code: KHS0AZ4JVK

ACETAMINOPHEN

Code: 362O9ITL9D

CODEINE ANHYDROUS

Code: UX6OWY2V7J

CAFFEINE

Code: 3G6A5W338E

Basic Information

Regulatory Information

Company Information

Active Ingredients

FD&C BLUE NO. 1

FD&C RED NO. 40

GELATIN, UNSPECIFIED

FD&C YELLOW NO. 6

TALC

MICROCRYSTALLINE CELLULOSE

SODIUM LAURYL SULFATE

STEARIC ACID

TITANIUM DIOXIDE

Active Moieties

BUTALBITAL

ACETAMINOPHEN

CODEINE ANHYDROUS

CAFFEINE