![MESALAMINE TABLET, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/52d96501-47f3-45d8-a181-98763b9f8965/f3177974-28c9-4318-bfde-ff1cd0bd0d8a-02.jpg)
| NDC | 70771-1110-2, 70771-1110-4, 70771-1110-8 |
| Set ID | 52d96501-47f3-45d8-a181-98763b9f8965 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Cadila Healthcare Limited |
| Generic Name | |
| Product Class | Aminosalicylate |
| Product Number | |
| Application Number | ANDA203286 |
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MESALAMINE
mesalamine tablet, delayed releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1110 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MESALAMINE (UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC) MESALAMINE 800 mg Inactive Ingredients Ingredient Name Strength ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FERRIC OXIDE RED (UNII: 1K09F3G675) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID (UNII: 1CS02G8656) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ISOPROPYL ALCOHOL (UNII: ND2M416302) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) AMMONIA (UNII: 5138Q19F1X) SHELLAC (UNII: 46N107B71O) Product Characteristics Color RED (REDDISH-BROWN) Score no score Shape CAPSULE (CAPSULE) Size 19mm Flavor Imprint Code 435 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1110-8 180 in 1 BOTTLE; Type 0: Not a Combination Product 08/02/2018 2 NDC:70771-1110-4 10 in 1 CARTON 08/02/2018 2 NDC:70771-1110-2 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 ANDA203286 08/02/2018 Labeler - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 918596198 ANALYSIS(70771-1110) , MANUFACTURE(70771-1110)
