ribavirin

Generic: ribavirin

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ribavirin
Generic Name ribavirin
Labeler zydus pharmaceuticals usa inc.
Dosage Form POWDER, FOR SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

ribavirin 6 g/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-395
Product ID 68382-395_5b244567-d037-4fbd-9e2b-ed394e1c07b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207366
Listing Expiration 2026-12-31
Marketing Start 2016-12-15

Pharmacologic Class

Established (EPC)
nucleoside analog antiviral [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382395
Hyphenated Format 68382-395

Supplemental Identifiers

RxCUI
312818
UPC
0368382395016
UNII
49717AWG6K
NUI
N0000175459 N0000175466

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ribavirin (source: ndc)
Generic Name ribavirin (source: ndc)
Application Number ANDA207366 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 6 g/1
source: ndc
Packaging
  • 4 VIAL in 1 CARTON (68382-395-04) / 1 POWDER, FOR SOLUTION in 1 VIAL
source: ndc

Packages (1)

68382-395-04 4 VIAL in 1 CARTON (68382-395-04) / 1 POWDER, FOR SOLUTION in 1 VIAL

Ingredients (1)

ribavirin (6 g/1)

Linked Drug Pages (1)

RIBAVIRIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "5b244567-d037-4fbd-9e2b-ed394e1c07b4", "openfda": {"nui": ["N0000175459", "N0000175466"], "upc": ["0368382395016"], "unii": ["49717AWG6K"], "rxcui": ["312818"], "spl_set_id": ["2c3a64d5-fde2-437b-bafc-e76dd187d85a"], "pharm_class_epc": ["Nucleoside Analog Antiviral [EPC]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 VIAL in 1 CARTON (68382-395-04)  / 1 POWDER, FOR SOLUTION in 1 VIAL", "package_ndc": "68382-395-04", "marketing_start_date": "20161215"}], "brand_name": "RIBAVIRIN", "product_id": "68382-395_5b244567-d037-4fbd-9e2b-ed394e1c07b4", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Nucleoside Analog Antiviral [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "68382-395", "generic_name": "ribavirin", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RIBAVIRIN", "active_ingredients": [{"name": "RIBAVIRIN", "strength": "6 g/1"}], "application_number": "ANDA207366", "marketing_category": "ANDA", "marketing_start_date": "20161215", "listing_expiration_date": "20261231"}