This site is intended for healthcare professionals
FDA Hero  Banner - Multi-coloured pills and tablets
FDA Drug information

Ribavirin

Read time: 1 mins
Marketing start date: 03 May 2024

Summary of product characteristics


Effective Time

20230927

Version

8

Spl Product Data Elements

Ribavirin Ribavirin RIBAVIRIN RIBAVIRIN CROSPOVIDONE (15 MPA.S AT 5%) FERRIC OXIDE YELLOW HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE TALC TITANIUM DIOXIDE FERRIC OXIDE RED SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE LIGHT PINK TO PINK ROUND ZC19 Ribavirin Ribavirin RIBAVIRIN RIBAVIRIN FERRIC OXIDE YELLOW HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE TALC TITANIUM DIOXIDE FERRIC OXIDE RED SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE LIGHT PINK TO PINK CAPSULE ZD;07 Ribavirin Ribavirin RIBAVIRIN RIBAVIRIN CROSPOVIDONE FERRIC OXIDE YELLOW HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE TALC TITANIUM DIOXIDE FERRIC OXIDE RED SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE LIGHT PINK TO PINK CAPSULE ZC56 Ribavirin Ribavirin RIBAVIRIN RIBAVIRIN CROSPOVIDONE FERRIC OXIDE YELLOW HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE TALC TITANIUM DIOXIDE FERRIC OXIDE RED SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE LIGHT PINK TO PINK CAPSULE ZD;08

Application Number

ANDA077094

Brand Name

Ribavirin

Generic Name

Ribavirin

Product Ndc

65841-129

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

NDC 65841-046-03 in bottle of 168 tablets Ribavirin Tablets , 200 mg R x only 168 tablets NDC 65841-603-07 in bottle of 56 tablets Ribavirin Tablets , 400 mg R x only 56 tablets NDC 65841-632-07 in bottle of 56 tablets Ribavirin Tablets , 500 mg R x only 56 tablets NDC 65841-129-07 in bottle of 56 tablets Ribavirin Tablets, 600 mg R x only 56 tablets Ribavirin tablets, 200 mg Ribavirin tablet ,400 mg Ribavirin Tablet 500 mg Ribavirin tablet 600 mg

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.