Label: ACETYLCYSTEINE injection, solution
- NDC Code(s): 70771-1412-1, 70771-1412-8
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 17, 2022
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INGREDIENTS AND APPEARANCE
ACETYLCYSTEINE
acetylcysteine injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1412 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETYLCYSTEINE (UNII: WYQ7N0BPYC) (ACETYLCYSTEINE - UNII:WYQ7N0BPYC) ACETYLCYSTEINE 200 mg in 1 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) NITROGEN (UNII: N762921K75) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1412-8 4 in 1 CARTON 01/17/2019 1 NDC:70771-1412-1 30 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208166 01/17/2019 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1412) , MANUFACTURE(70771-1412)
