NDC 66435-103

RIBASPHERE

Ribavirin

RIBASPHERE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Kadmon Pharmaceuticals, Llc. The primary component is Ribavirin.

• Product ID: 66435-103_dffc1bdc-d81c-457e-ace7-ee5c6032f7b0
• NDC: 66435-103
• Product Type: Human Prescription Drug
• Proprietary Name: RIBASPHERE
• Generic Name: Ribavirin
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2005-12-05
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077456
• Labeler Name: Kadmon Pharmaceuticals, LLC
• Substance Name: RIBAVIRIN
• Active Ingredient Strength: 400 mg/1
• Pharm Classes: Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 66435-103-56

56 TABLET, FILM COATED in 1 BOTTLE (66435-103-56)

• Marketing Start Date: 2005-12-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66435-103-95 [66435010395]

RIBASPHERE TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077456
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2005-12-05
• Marketing End Date: 2010-06-29

NDC 66435-103-56 [66435010356]

RIBASPHERE TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077456
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-12-05
• Marketing End Date: 2019-09-30

Drug Details

Active Ingredients

Ingredient	Strength
RIBAVIRIN	400 mg/1

OpenFDA Data

• SPL SET ID: 12f3dec1-4299-4b93-8013-6fa6a963fd81
• Manufacturer:
  • Kadmon Pharmaceuticals, LLC
• UNII:
  • 49717AWG6K
• RxNorm Concept Unique ID - RxCUI:
  • 616133
  • 616131
  • 896790
  • 902313
  • 902312
  • 248109
  • 616129
  • 1863148
  • 1298334
  • 757599
  • 597718
  • 754738
  • 597722
  • 757597

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
66435-102	RIBASPHERE	RIBASPHERE
66435-104	RIBASPHERE	RIBASPHERE
66435-101	Ribasphere	Ribasphere
66435-103	RIBASPHERE	RIBASPHERE
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
0187-0007	Virazole	Ribavirin