Label: ZALDYON- mesalamine tablet, delayed release
- NDC Code(s): 70771-1353-2, 70771-1353-4, 70771-1353-8
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 17, 2022
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INGREDIENTS AND APPEARANCE
ZALDYON
mesalamine tablet, delayed releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1353 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:70771-1353-4 10 in 1 CARTON 01/17/2019 1 NDC:70771-1353-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:70771-1353-8 180 in 1 BOTTLE; Type 0: Not a Combination Product 01/17/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203286 01/17/2019 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1353) , MANUFACTURE(70771-1353)
