Label: PHYTONADIONE tablet
- NDC Code(s): 70771-1318-1, 70771-1318-2, 70771-1318-3, 70771-1318-4
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 1, 2022
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INGREDIENTS AND APPEARANCE
PHYTONADIONE
phytonadione tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1318 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857) PHYTONADIONE 5 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color YELLOW (LIGHT YELLOW TO YELLOW) Score 2 pieces Shape ROUND (ROUND) Size 7mm Flavor Imprint Code 1014 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1318-1 1 in 1 CARTON 02/22/2019 1 100 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:70771-1318-4 10 in 1 CARTON 02/22/2019 2 NDC:70771-1318-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:70771-1318-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210189 02/22/2019 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (863362789) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1318) , MANUFACTURE(70771-1318)
