Label: CHLORTHALIDONE tablet
- NDC Code(s): 70771-1369-0, 70771-1369-1, 70771-1370-0, 70771-1370-1
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 4, 2022
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INGREDIENTS AND APPEARANCE
CHLORTHALIDONE
chlorthalidone tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1369 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORTHALIDONE (UNII: Q0MQD1073Q) (CHLORTHALIDONE - UNII:Q0MQD1073Q) CHLORTHALIDONE 25 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color YELLOW (LIGHT YELLOW) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code Z25 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1369-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2019 2 NDC:70771-1369-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207813 05/15/2019 CHLORTHALIDONE
chlorthalidone tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1370 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORTHALIDONE (UNII: Q0MQD1073Q) (CHLORTHALIDONE - UNII:Q0MQD1073Q) CHLORTHALIDONE 50 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE (WHITE) Score 2 pieces Shape ROUND (ROUND) Size 7mm Flavor Imprint Code Z;50 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1370-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2019 2 NDC:70771-1370-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207813 05/15/2019 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1369, 70771-1370) , MANUFACTURE(70771-1369, 70771-1370)
