RIBAVIRIN- ribavirin capsule 
Zydus Lifesciences Limited

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RIBAVIRIN CAPSULES

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-260-12 in bottle of 84 capsules

Ribavirin Capsules USP, 200 mg

Rx only

84 capsules

Ribavirin Capsules, 200 mg
RIBAVIRIN 
ribavirin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-260
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)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
GELATIN (UNII: 2G86QN327L)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size22mm
FlavorImprint Code ZA;12;200mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-260-3010 in 1 CARTON01/25/200603/25/2025
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:65841-260-0442 in 1 BOTTLE; Type 0: Not a Combination Product01/25/200603/25/2025
3NDC:65841-260-0756 in 1 BOTTLE; Type 0: Not a Combination Product01/25/200603/25/2025
4NDC:65841-260-0970 in 1 BOTTLE; Type 0: Not a Combination Product01/25/200603/25/2025
5NDC:65841-260-1284 in 1 BOTTLE; Type 0: Not a Combination Product01/25/200603/25/2025
6NDC:65841-260-13140 in 1 BOTTLE; Type 0: Not a Combination Product01/25/200603/25/2025
7NDC:65841-260-03168 in 1 BOTTLE; Type 0: Not a Combination Product01/25/200603/25/2025
8NDC:65841-260-28180 in 1 BOTTLE; Type 0: Not a Combination Product01/25/200603/25/2025
9NDC:65841-260-101000 in 1 BOTTLE; Type 0: Not a Combination Product01/25/200603/25/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07722401/25/200605/09/2025
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-260) , MANUFACTURE(65841-260)

Revised: 5/2025
Document Id: 8a217fa5-15ac-4746-9c24-3070b6161649
Set id: b97cd49c-9e19-4a35-987c-06e62bb25b6b
Version: 10
Effective Time: 20250509
 
Zydus Lifesciences Limited