BUPAP

Basic Information

Product Name

BUPAP

FDA Product Code

0095-3000

Regulatory Information

NDC Product Code

0095-3000

Application Number

ANDA090956

Marketing Category

C73584

Effective Date

April 30, 2020

Territorial Authority

USA

FDA Title

BUPAP (Butalbital and Acetaminophen) Tablets 50 mg/300 mg

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

14

Active Ingredients

ACETAMINOPHEN

Quantity: 300 mg in 1 1

Code: 362O9ITL9D

Class Code: ACTIB

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

BUTALBITAL

Quantity: 50 mg in 1 1

Code: KHS0AZ4JVK

Class Code: ACTIB

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

BUTALBITAL

Code: KHS0AZ4JVK

ACETAMINOPHEN

Code: 362O9ITL9D

Basic Information

Regulatory Information

Company Information

Active Ingredients

STARCH, CORN

D&C YELLOW NO. 10

CROSCARMELLOSE SODIUM

FD&C RED NO. 40

MICROCRYSTALLINE CELLULOSE

MAGNESIUM STEARATE

Active Moieties

BUTALBITAL

ACETAMINOPHEN