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Bromocriptine Capsules

Generic name: bromocriptine mesylate
Dosage form: capsule
Drug class: Dopaminergic antiparkinsonism agents, Prolactin inhibitors

Medically reviewed by Drugs.com. Last updated on Apr 1, 2020.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-654-01 in bottle of 100 Capsules

Bromocriptine Mesylate Capsules USP, 5 mg

Rx only

100 Capsules

BROMOCRIPTINE MESYLATE
bromocriptine mesylate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65841-654
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMOCRIPTINE MESYLATE (BROMOCRIPTINE) BROMOCRIPTINE 5 mg
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
AMMONIA
BUTYL ALCOHOL
CARRAGEENAN
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
HYPROMELLOSE 2910 (15 MPA.S)
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MALEIC ACID
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
TITANIUM DIOXIDE
WATER
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
1 NDC:65841-654-06 30 CAPSULE in 1 BOTTLE
2 NDC:65841-654-01 100 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078899 01/23/2009
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS(65841-654), MANUFACTURE(65841-654)
Cadila Healthcare Limited