Label: NITROGLYCERIN tablet
- NDC Code(s): 70771-1717-1, 70771-1718-1, 70771-1718-4, 70771-1719-1
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 13, 2022
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INGREDIENTS AND APPEARANCE
NITROGLYCERIN
nitroglycerin tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1717 Route of Administration SUBLINGUAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN 0.3 mg Inactive Ingredients Ingredient Name Strength CALCIUM STEARATE (UNII: 776XM7047L) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (OFF WHITE) Score no score Shape ROUND Size 4mm Flavor Imprint Code 3;T Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1717-1 1 in 1 CARTON 02/02/2023 1 100 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210153 02/02/2023 NITROGLYCERIN
nitroglycerin tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1718 Route of Administration SUBLINGUAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN 0.4 mg Inactive Ingredients Ingredient Name Strength CALCIUM STEARATE (UNII: 776XM7047L) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (OFF WHITE) Score no score Shape ROUND Size 4mm Flavor Imprint Code 4;T Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1718-1 1 in 1 CARTON 02/02/2023 1 100 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:70771-1718-4 4 in 1 CARTON 02/02/2023 2 25 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210153 02/02/2023 NITROGLYCERIN
nitroglycerin tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1719 Route of Administration SUBLINGUAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN 0.6 mg Inactive Ingredients Ingredient Name Strength CALCIUM STEARATE (UNII: 776XM7047L) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (OFF WHITE) Score no score Shape ROUND Size 4mm Flavor Imprint Code 6;T Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1719-1 1 in 1 CARTON 02/02/2023 1 100 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210153 02/02/2023 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1717, 70771-1718, 70771-1719) , MANUFACTURE(70771-1717, 70771-1718, 70771-1719)
