![LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/6b098fd2-b0ee-42f9-97bc-837768dc4788/092a3521-7876-46c0-ad27-8f7fa994f7e2-03.jpg)
![LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/6b098fd2-b0ee-42f9-97bc-837768dc4788/092a3521-7876-46c0-ad27-8f7fa994f7e2-04.jpg)
| NDC | 65841-732-06, 65841-732-10, 65841-732-16, 65841-732-40, 65841-733-06, 65841-733-10, 65841-733-16, 65841-733-23 |
| Set ID | 6b098fd2-b0ee-42f9-97bc-837768dc4788 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Cadila Healthcare Limited |
| Generic Name | |
| Product Class | Angiotensin 2 Receptor Blocker |
| Product Number | |
| Application Number | ANDA078385 |
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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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 - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 918596198 ANALYSIS(65841-732, 65841-733) , MANUFACTURE(65841-732, 65841-733)
