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- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AZATHIOPRINE
azathioprine tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-602 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L) AZATHIOPRINE 50 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color YELLOW (YELLOW) Score 2 pieces Shape ROUND (ROUND) Size 8mm Flavor Imprint Code ZC;59 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-602-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/11/2007 2 NDC:65841-602-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 07/11/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077621 07/11/2007 Labeler - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 918596198 ANALYSIS(65841-602) , MANUFACTURE(65841-602)
