Label: AZATHIOPRINE tablet
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NDC Code(s):
70771-1139-1,
70771-1139-5,
70771-1140-1,
70771-1140-5, view more70771-1141-1, 70771-1141-5
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 5, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AZATHIOPRINE
azathioprine tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1139 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L) AZATHIOPRINE 25 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 6mm Flavor Imprint Code ZD;11 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1139-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 2 NDC:70771-1139-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077621 12/02/2017 AZATHIOPRINE
azathioprine tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1140 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L) AZATHIOPRINE 75 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 9mm Flavor Imprint Code ZD;10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1140-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 2 NDC:70771-1140-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077621 12/02/2017 AZATHIOPRINE
azathioprine tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1141 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L) AZATHIOPRINE 100 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 10mm Flavor Imprint Code ZD;09 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1141-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 2 NDC:70771-1141-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077621 12/02/2017 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1139, 70771-1140, 70771-1141) , MANUFACTURE(70771-1139, 70771-1140, 70771-1141)
