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![TAMOXIFEN CITRATE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/70052366-80f3-41bc-b2dd-c1efe9317243/0cc21728-8fb0-43e5-ac53-4433e8ae1ea1-03.jpg)
| NDC | 70771-1184-1, 70771-1184-2, 70771-1184-3, 70771-1184-4, 70771-1184-5, 70771-1184-6, 70771-1184-9, 70771-1185-1, 70771-1185-2, 70771-1185-3, 70771-1185-4, 70771-1185-5, 70771-1185-6, 70771-1185-9 |
| Set ID | 70052366-80f3-41bc-b2dd-c1efe9317243 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Cadila Healthcare Limited |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | ANDA206694 |
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TAMOXIFEN CITRATE
tamoxifen citrate tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1184 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TAMOXIFEN CITRATE (UNII: 7FRV7310N6) (TAMOXIFEN - UNII:094ZI81Y45) TAMOXIFEN 10 mg Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 7mm Flavor Imprint Code 826 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1184-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2018 2 NDC:70771-1184-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2018 3 NDC:70771-1184-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2018 4 NDC:70771-1184-8 180 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206694 01/03/2018 TAMOXIFEN CITRATE
tamoxifen citrate tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1185 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TAMOXIFEN CITRATE (UNII: 7FRV7310N6) (TAMOXIFEN - UNII:094ZI81Y45) TAMOXIFEN 20 mg Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 9mm Flavor Imprint Code 827 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1185-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2018 2 NDC:70771-1185-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2018 3 NDC:70771-1185-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2018 4 NDC:70771-1185-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2018 5 NDC:70771-1185-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206694 01/03/2018 Labeler - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 863362789 ANALYSIS(70771-1184, 70771-1185) , MANUFACTURE(70771-1184, 70771-1185)
