MedPath
FDA Product

Butalbital, aspirin, and caffeine

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

Basic Information

Butalbital, aspirin, and caffeine

0527-1552

Regulatory Information

0527-1552

ANDA086996

C73584

January 30, 2024

USA

Butalbital, Aspirin, and Caffeine Capsules CIIIRx Only

HUMAN PRESCRIPTION DRUG LABEL

17

Company Information

002277481

Active Ingredients

ASPIRIN

Quantity: 325 mg in 1 1

Code: R16CO5Y76E

Class Code: ACTIB

CAFFEINE

Quantity: 40 mg in 1 1

Code: 3G6A5W338E

Class Code: ACTIB

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

BUTALBITAL

Quantity: 50 mg in 1 1

Code: KHS0AZ4JVK

Class Code: ACTIB

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TRIMYRISTIN

Code: 18L31PSR28

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

FD&C GREEN NO. 3

Code: 3P3ONR6O1S

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

METHYL ALCOHOL

Code: Y4S76JWI15

Class Code: IACT

ALUMINUM OXIDE

Code: LMI26O6933

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

Active Moieties

CAFFEINE

Code: 3G6A5W338E

ASPIRIN

Code: R16CO5Y76E

BUTALBITAL

Code: KHS0AZ4JVK

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