![ITRACONAZOLE CAPSULE [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/a545b2bd-ef19-4d0d-b7f6-c695173eaa3c/7a68f200-7089-496a-8100-da799c4ec244-02.jpg)
| NDC | 70771-1208-0, 70771-1208-1, 70771-1208-2, 70771-1208-3, 70771-1208-4 |
| Set ID | a545b2bd-ef19-4d0d-b7f6-c695173eaa3c |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Cadila Healthcare Limited |
| Generic Name | |
| Product Class | Azole Antifungal |
| Product Number | |
| Application Number | ANDA204672 |
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ITRACONAZOLE
itraconazole capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1208 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ITRACONAZOLE (UNII: 304NUG5GF4) (ITRACONAZOLE - UNII:304NUG5GF4) ITRACONAZOLE 100 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) GELATIN (UNII: 2G86QN327L) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) ALCOHOL (UNII: 3K9958V90M) ISOPROPYL ALCOHOL (UNII: ND2M416302) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SHELLAC (UNII: 46N107B71O) AMMONIA (UNII: 5138Q19F1X) POLOXAMER 188 (UNII: LQA7B6G8JG) Product Characteristics Color BLUE (BLUE) Score no score Shape CAPSULE (CAPSULE) Size 23mm Flavor Imprint Code ZA;65;100;mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1208-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/06/2018 2 NDC:70771-1208-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/06/2018 3 NDC:70771-1208-4 10 in 1 CARTON 03/06/2018 3 NDC:70771-1208-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:70771-1208-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/06/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204672 03/06/2018 Labeler - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 918596198 ANALYSIS(70771-1208) , MANUFACTURE(70771-1208)
