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- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CYPROHEPTADINE HYDROCHLORIDE
cyproheptadine hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1076 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYPROHEPTADINE HYDROCHLORIDE (UNII: NJ82J0F8QC) (CYPROHEPTADINE - UNII:2YHB6175DO) CYPROHEPTADINE HYDROCHLORIDE 4 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color WHITE (White) Score 2 pieces Shape ROUND (Round) Size 7mm Flavor Imprint Code 1110 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1076-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2017 2 NDC:70771-1076-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208938 07/20/2017 Labeler - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 863362789 ANALYSIS(70771-1076) , MANUFACTURE(70771-1076)
