Label: BROMOCRIPTINE MESYLATE capsule
- NDC Code(s): 65841-654-01, 65841-654-06
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 4, 2022
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INGREDIENTS AND APPEARANCE
BROMOCRIPTINE MESYLATE
bromocriptine mesylate capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-654 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMOCRIPTINE MESYLATE (UNII: FFP983J3OD) (BROMOCRIPTINE - UNII:3A64E3G5ZO) BROMOCRIPTINE 5 mg Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) AMMONIA (UNII: 5138Q19F1X) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) CARRAGEENAN (UNII: 5C69YCD2YJ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W) ISOPROPYL ALCOHOL (UNII: ND2M416302) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MALEIC ACID (UNII: 91XW058U2C) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color BROWN (TAN) , WHITE (WHITE) Score no score Shape CAPSULE (CAPSULE) Size 16mm Flavor Imprint Code ZA17;5mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-654-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/23/2009 2 NDC:65841-654-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/23/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078899 01/23/2009 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-654) , MANUFACTURE(65841-654)
