Label: LINEZOLID tablet, film coated
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NDC Code(s):
70771-1111-0,
70771-1111-1,
70771-1111-2,
70771-1111-3, view more70771-1111-5, 70771-1111-9
- 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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- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LINEZOLID
linezolid tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1111 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LINEZOLID (UNII: ISQ9I6J12J) (LINEZOLID - UNII:ISQ9I6J12J) LINEZOLID 600 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSPOVIDONE (UNII: 2S7830E561) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape OVAL (OVAL) Size 19mm Flavor Imprint Code 413 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1111-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 08/09/2017 2 NDC:70771-1111-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/09/2017 3 NDC:70771-1111-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/09/2017 4 NDC:70771-1111-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/09/2017 5 NDC:70771-1111-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/09/2017 6 NDC:70771-1111-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/09/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206097 08/09/2017 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1111) , MANUFACTURE(70771-1111)