![MESALAMINE TABLET, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/29c0dd58-d2cf-40fa-bc32-0eab61937331/0597b64c-aa1f-42bd-8fc0-49fb44ca0124-02.jpg)
| NDC | 70771-1071-1, 70771-1071-2 |
| Set ID | 29c0dd58-d2cf-40fa-bc32-0eab61937331 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Cadila Healthcare Limited |
| Generic Name | |
| Product Class | Aminosalicylate |
| Product Number | |
| Application Number | ANDA091640 |
- 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:70771-1071 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MESALAMINE (UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC) MESALAMINE 1.2 g Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID (UNII: 1CS02G8656) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color RED (BROWN) Score no score Shape OVAL (OVAL) Size 10mm Flavor Imprint Code 711 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1071-2 34 in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2017 2 NDC:70771-1071-1 120 in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091640 06/19/2017 Labeler - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 918596198 ANALYSIS(70771-1071) , MANUFACTURE(70771-1071)
