![HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/1aa44bff-9a62-48b4-a520-98d7d524e3a9/058168d6-cd19-4068-ada5-845fa6f5d8c2-02.jpg)
| NDC | 65841-633-01, 65841-633-05, 65841-633-30 |
| Set ID | 1aa44bff-9a62-48b4-a520-98d7d524e3a9 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Cadila Healthcare Limited |
| Generic Name | |
| Product Class | Antimalarial, Antirheumatic Agent |
| Product Number | |
| Application Number | ANDA040657 |
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDROXYCHLOROQUINE SULFATE
hydroxychloroquine sulfate tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-633 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROXYCHLOROQUINE SULFATE (UNII: 8Q2869CNVH) (HYDROXYCHLOROQUINE - UNII:4QWG6N8QKH) HYDROXYCHLOROQUINE SULFATE 200 mg Inactive Ingredients Ingredient Name Strength DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape OVAL (CAPSULE) Size 13mm Flavor Imprint Code ZC38 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-633-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2008 2 NDC:65841-633-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2008 3 NDC:65841-633-30 10 in 1 CARTON 01/03/2008 3 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 ANDA040657 01/03/2008 Labeler - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 918596198 ANALYSIS(65841-633) , MANUFACTURE(65841-633)
