Label: ALBENDAZOLE tablet, film coated
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NDC Code(s):
70771-1103-1,
70771-1103-3,
70771-1103-5,
70771-1103-6, view more70771-1103-7, 70771-1103-8
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 13, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALBENDAZOLE
albendazole tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1103 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALBENDAZOLE (UNII: F4216019LN) (ALBENDAZOLE - UNII:F4216019LN) ALBENDAZOLE 200 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE K30 (UNII: U725QWY32X) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (WHITE TO OFF WHITE) Score no score Shape ROUND (ROUND) Size 12mm Flavor Imprint Code 1021 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1103-7 28 in 1 BOTTLE; Type 0: Not a Combination Product 12/17/2018 2 NDC:70771-1103-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/17/2018 3 NDC:70771-1103-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/17/2018 4 NDC:70771-1103-8 1 in 1 BOTTLE 12/17/2018 4 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:70771-1103-6 2 in 1 BOTTLE; Type 0: Not a Combination Product 05/11/2020 6 NDC:70771-1103-3 1 in 1 CARTON 05/27/2020 6 2 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 ANDA208979 12/17/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1103) , MANUFACTURE(70771-1103)
