RIBAVIRIN - ribavirin tablet, film coated 
Zydus Lifesciences Limited

----------

RIBAVIRIN TABLETS

NDC 65841-046-03 in bottle of 168 tablets

Ribavirin  Tablets , 200 mg

Rx only

168 tablets

Ribavirin tablets, 200 mg

NDC 65841-603-07 in bottle of 56 tablets

Ribavirin  Tablets , 400 mg

Rx only

56 tablets

Ribavirin tablet ,400 mg

NDC 65841-632-07 in bottle of 56 tablets

Ribavirin  Tablets , 500 mg

Rx only

56 tablets

Ribavirin Tablet 500 mg

NDC 65841-129-07 in bottle of 56 tablets

Ribavirin Tablets, 600 mg

Rx only

56 tablets

Ribavirin tablet 600 mg
RIBAVIRIN 
ribavirin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-046
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RIBAVIRIN (UNII: 49717AWG6K) (RIBAVIRIN - UNII:49717AWG6K) RIBAVIRIN200 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorPINK (LIGHT PINK TO PINK) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code ZC19
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-046-03168 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
2NDC:65841-046-28180 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
3NDC:65841-046-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
4NDC:65841-046-7710 in 1 CARTON12/05/2005
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07709412/05/2005
RIBAVIRIN 
ribavirin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-603
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RIBAVIRIN (UNII: 49717AWG6K) (RIBAVIRIN - UNII:49717AWG6K) RIBAVIRIN400 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorPINK (LIGHT PINK TO PINK) Scoreno score
ShapeOVAL (CAPSULE) Size17mm
FlavorImprint Code ZD;07
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-603-1728 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
2NDC:65841-603-0756 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
3NDC:65841-603-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07709412/05/2005
RIBAVIRIN 
ribavirin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-632
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RIBAVIRIN (UNII: 49717AWG6K) (RIBAVIRIN - UNII:49717AWG6K) RIBAVIRIN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (UNII: 2S7830E561)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorPINK (LIGHT PINK TO PINK) Scoreno score
ShapeOVAL (CAPSULE) Size18mm
FlavorImprint Code ZC56
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-632-1728 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
2NDC:65841-632-0756 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
3NDC:65841-632-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07709412/05/2005
RIBAVIRIN 
ribavirin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-129
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RIBAVIRIN (UNII: 49717AWG6K) (RIBAVIRIN - UNII:49717AWG6K) RIBAVIRIN600 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (UNII: 2S7830E561)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorPINK (LIGHT PINK TO PINK) Scoreno score
ShapeOVAL (CAPSULE) Size21mm
FlavorImprint Code ZD;08
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-129-1728 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
2NDC:65841-129-0756 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
3NDC:65841-129-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07709412/05/2005
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-046, 65841-603, 65841-632, 65841-129) , MANUFACTURE(65841-046, 65841-603, 65841-632, 65841-129)

Revised: 10/2022
Document Id: f293abc5-ab36-475c-bd31-b473e926edc0
Set id: 666e8b22-f519-460b-a774-88a621d56139
Version: 7
Effective Time: 20221013
 
Zydus Lifesciences Limited