Ribavirin

Basic Information

Product Name

Ribavirin

FDA Product Code

68382-127

Regulatory Information

NDC Product Code

68382-127

Application Number

ANDA077094

Marketing Category

C73584

Effective Date

November 10, 2022

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use RIBAVIRIN TABLETS safely and effectively. See full prescribing information for RIBAVIRIN TABLETS. RIBAVIRIN tablets, for oral useInitial U.S. Approval: 2002

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

RIBAVIRIN

Quantity: 400 mg in 1 1

Code: 49717AWG6K

Class Code: ACTIB

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

Active Moieties

Code: 49717AWG6K

Ribavirin

Basic Information

Regulatory Information

Company Information

Active Ingredients

FERRIC OXIDE YELLOW

HYPROMELLOSES

POVIDONE

CROSPOVIDONE

MAGNESIUM STEARATE

FERRIC OXIDE RED

TALC

POLYETHYLENE GLYCOL, UNSPECIFIED

SILICON DIOXIDE

TITANIUM DIOXIDE

CELLULOSE, MICROCRYSTALLINE

Active Moieties

RIBAVIRIN