NDC 0187-0007

Virazole

Ribavirin

Virazole is a Respiratory (inhalation) Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Valeant Pharmaceuticals North America Llc. The primary component is Ribavirin.

• Product ID: 0187-0007_475531fa-6496-4ab4-bb9b-54fd1fcb36ad
• NDC: 0187-0007
• Product Type: Human Prescription Drug
• Proprietary Name: Virazole
• Generic Name: Ribavirin
• Dosage Form: Powder, For Solution
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 1986-01-01
• Marketing Category: NDA / NDA
• Application Number: NDA018859
• Labeler Name: Valeant Pharmaceuticals North America LLC
• Substance Name: RIBAVIRIN
• Active Ingredient Strength: 6 g/1
• Pharm Classes: Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0187-0007-01

1 VIAL, GLASS in 1 CARTON (0187-0007-01) > 1 POWDER, FOR SOLUTION in 1 VIAL, GLASS

• Marketing Start Date: 2019-08-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0187-0007-01 [00187000701]

Virazole POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA018859
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-08-27

NDC 0187-0007-14 [00187000714]

Virazole POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA018859
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1986-01-01

Drug Details

Active Ingredients

Ingredient	Strength
RIBAVIRIN	6 g/1

OpenFDA Data

• SPL SET ID: adf16e64-345f-469a-b987-3fbdd17e0ac2
• Manufacturer:
  • Valeant Pharmaceuticals North America LLC
• UNII:
  • 49717AWG6K
• RxNorm Concept Unique ID - RxCUI:
  • 207406
  • 312818

Pharmacological Class

• Nucleoside Analog [EXT]
• Nucleoside Analog Antiviral [EPC]

NDC Crossover Matching brand name "Virazole" or generic name "Ribavirin"

NDC	Brand Name	Generic Name
0187-0007	Virazole	Ribavirin
0074-3197	Moderiba	Ribavirin
0074-3282	Moderiba	Ribavirin
0085-1318	REBETOL	ribavirin
0781-2043	Ribavirin	Ribavirin
0781-5177	Ribavirin	Ribavirin
42494-423	Ribavirin	Ribavirin
53808-0781	Ribavirin	RIBAVIRIN
53808-0782	Ribavirin	RIBAVIRIN
54738-950	ribavirin	ribavirin
54738-951	ribavirin	ribavirin
54738-952	ribavirin	ribavirin
54738-953	ribavirin	ribavirin
63629-2149	Ribavirin	Ribavirin
65841-046	Ribavirin	Ribavirin
65841-129	Ribavirin	Ribavirin
65841-260	Ribavirin	Ribavirin
65841-603	Ribavirin	Ribavirin
65841-632	Ribavirin	Ribavirin
65862-207	Ribavirin	Ribavirin