Label: RIBAVIRIN capsule
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NDC Code(s):
65841-260-03,
65841-260-04,
65841-260-07,
65841-260-09, view more65841-260-10, 65841-260-12, 65841-260-13, 65841-260-28, 65841-260-30
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 27, 2023
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INGREDIENTS AND APPEARANCE
RIBAVIRIN
ribavirin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-260 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RIBAVIRIN (UNII: 49717AWG6K) (RIBAVIRIN - UNII:49717AWG6K) RIBAVIRIN 200 mg Inactive Ingredients Ingredient Name Strength 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 Color WHITE (WHITE) Score no score Shape CAPSULE (CAPSULE) Size 22mm Flavor Imprint Code ZA;12;200mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-260-30 10 in 1 CARTON 01/25/2006 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:65841-260-04 42 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2006 3 NDC:65841-260-07 56 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2006 4 NDC:65841-260-09 70 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2006 5 NDC:65841-260-12 84 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2006 6 NDC:65841-260-13 140 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2006 7 NDC:65841-260-03 168 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2006 8 NDC:65841-260-28 180 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2006 9 NDC:65841-260-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077224 01/25/2006 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-260) , MANUFACTURE(65841-260)
