Label: METHOTREXATE tablet
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NDC Code(s):
70771-1058-0,
70771-1058-1,
70771-1058-2,
70771-1058-3, view more70771-1058-5, 70771-1058-7, 70771-1058-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 5, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
METHOTREXATE
methotrexate tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1058 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHOTREXATE (UNII: YL5FZ2Y5U1) (METHOTREXATE - UNII:YL5FZ2Y5U1) METHOTREXATE 2.5 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color YELLOW (YELLOW) Score 2 pieces Shape ROUND (ROUND) Size 6mm Flavor Imprint Code L2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1058-3 36 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2017 2 NDC:70771-1058-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2017 3 NDC:70771-1058-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2017 4 NDC:70771-1058-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2017 5 NDC:70771-1058-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2017 6 NDC:70771-1058-7 100 in 1 CARTON 02/09/2017 6 NDC:70771-1058-2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207812 02/09/2017 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Pharmaceuticals USA Inc. (156861945) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1058) , MANUFACTURE(70771-1058)
