Label: ATENOLOL AND CHLORTHALIDONE tablet
- NDC Code(s): 70771-1372-1, 70771-1373-1
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 2, 2022
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INGREDIENTS AND APPEARANCE
ATENOLOL AND CHLORTHALIDONE
atenolol and chlorthalidone tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1372 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI) ATENOLOL 50 mg CHLORTHALIDONE (UNII: Q0MQD1073Q) (CHLORTHALIDONE - UNII:Q0MQD1073Q) CHLORTHALIDONE 25 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (WHITE TO OFF WHITE) Score 2 pieces Shape ROUND (ROUND) Size 8mm Flavor Imprint Code 11;67 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1372-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/12/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210028 03/12/2019 ATENOLOL AND CHLORTHALIDONE
atenolol and chlorthalidone tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1373 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI) ATENOLOL 100 mg CHLORTHALIDONE (UNII: Q0MQD1073Q) (CHLORTHALIDONE - UNII:Q0MQD1073Q) CHLORTHALIDONE 25 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (WHITE TO OFF WHITE) Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code 11;68 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1373-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/12/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210028 03/12/2019 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1372, 70771-1373) , MANUFACTURE(70771-1372, 70771-1373)
