Carisoprodol

Basic Information

Product Name

Carisoprodol

FDA Product Code

50436-0451

Regulatory Information

NDC Product Code

50436-0451

Application Number

ANDA205085

Marketing Category

C73584

Effective Date

September 17, 2018

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use CARISOPRODOL tablets, USP safely and effectively. See full prescribing information for CARISOPRODOL tablets, USP. CARISOPRODOL Tablets, USP for Oral use CIV Initial U.S. Approval: 1959

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

CARISOPRODOL

Quantity: 350 mg in 1 1

Code: 21925K482H

Class Code: ACTIB

Active Moieties

Code: 21925K482H

Carisoprodol

Basic Information

Regulatory Information

Company Information

Active Ingredients

CROSCARMELLOSE SODIUM

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE

POVIDONE, UNSPECIFIED

MICROCRYSTALLINE CELLULOSE

TALC

STARCH, CORN

Active Moieties

CARISOPRODOL