Label: LOSARTAN POTASSIUM tablet, film coated
-
NDC Code(s):
65841-729-01,
65841-729-06,
65841-729-10,
65841-729-16, view more65841-729-24, 65841-730-01, 65841-730-06, 65841-730-10, 65841-730-16, 65841-730-24, 65841-731-01, 65841-731-06, 65841-731-10, 65841-731-16, 65841-731-30, 65841-731-77
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 18, 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
-
INGREDIENTS AND APPEARANCE
LOSARTAN POTASSIUM
losartan potassium tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-729 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89) LOSARTAN POTASSIUM 25 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14) STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape CAPSULE (CAPSULE) Size 8mm Flavor Imprint Code Z;2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-729-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/04/2010 2 NDC:65841-729-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/04/2010 3 NDC:65841-729-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/04/2010 4 NDC:65841-729-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 10/04/2010 5 NDC:65841-729-24 10000 in 1 BOTTLE; Type 0: Not a Combination Product 10/04/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078243 10/04/2010 LOSARTAN POTASSIUM
losartan potassium tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-730 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89) LOSARTAN POTASSIUM 50 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14) STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces Shape CAPSULE (CAPSULE) Size 11mm Flavor Imprint Code Z16 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-730-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/04/2010 2 NDC:65841-730-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/04/2010 3 NDC:65841-730-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/04/2010 4 NDC:65841-730-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 10/04/2010 5 NDC:65841-730-24 10000 in 1 BOTTLE; Type 0: Not a Combination Product 10/04/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078243 10/04/2010 LOSARTAN POTASSIUM
losartan potassium tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-731 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89) LOSARTAN POTASSIUM 100 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14) STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape CAPSULE (CAPSULE) Size 12mm Flavor Imprint Code Z18 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-731-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/04/2010 2 NDC:65841-731-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/04/2010 3 NDC:65841-731-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/04/2010 4 NDC:65841-731-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 10/04/2010 5 NDC:65841-731-77 10 in 1 CARTON 10/04/2010 5 NDC:65841-731-30 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078243 10/04/2010 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 677605858 ANALYSIS(65841-729, 65841-730, 65841-731) , MANUFACTURE(65841-729, 65841-730, 65841-731) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-729, 65841-730, 65841-731) , MANUFACTURE(65841-729, 65841-730, 65841-731)
