Label: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE tablet, film coated
-
NDC Code(s):
65841-732-06,
65841-732-10,
65841-732-16,
65841-732-40, view more65841-733-06, 65841-733-10, 65841-733-16, 65841-733-23
- 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
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 AND HYDROCHLOROTHIAZIDE
losartan potassium and hydrochlorothiazide tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-732 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE 12.5 mg 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 no score Shape CAPSULE (CAPSULE) Size 12mm Flavor Imprint Code ZD18 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-732-40 5000 in 1 BOTTLE; Type 0: Not a Combination Product 04/10/2010 2 NDC:65841-732-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/10/2010 3 NDC:65841-732-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/10/2010 4 NDC:65841-732-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/10/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078385 04/10/2010 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
losartan potassium and hydrochlorothiazide tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-733 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE 25 mg 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 13mm Flavor Imprint Code ZD19 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-733-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/10/2010 2 NDC:65841-733-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/10/2010 3 NDC:65841-733-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/10/2010 4 NDC:65841-733-23 4000 in 1 BOTTLE; Type 0: Not a Combination Product 04/10/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078385 04/10/2010 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-732, 65841-733) , MANUFACTURE(65841-732, 65841-733)
