Label: DEXAMETHASONE tablet
- NDC Code(s): 70771-1706-1
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 13, 2024
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INGREDIENTS AND APPEARANCE
DEXAMETHASONE
dexamethasone tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1706 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL) DEXAMETHASONE 1 mg Inactive Ingredients Ingredient Name Strength FERRIC OXIDE YELLOW (UNII: EX438O2MRT) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) SUCROSE (UNII: C151H8M554) Product Characteristics Color YELLOW (light yellow to yellow colored) Score 2 pieces Shape ROUND Size 6mm Flavor Imprint Code 1793 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1706-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/13/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA216284 05/13/2024 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 677605858 ANALYSIS(70771-1706) , MANUFACTURE(70771-1706)