BROMOCRIPTINE MESYLATE capsule

Bromocriptine mesylate by

Drug Labeling and Warnings

Bromocriptine mesylate by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 65841-654-01 in bottle of 100 Capsules

Bromocriptine Mesylate Capsules USP, 5 mg

Rx only

100 Capsules

INGREDIENTS AND APPEARANCE

BROMOCRIPTINE MESYLATE 
bromocriptine mesylate capsule

Product 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 - Cadila Healthcare Limited (918596198)

Registrant - Cadila Healthcare Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Cadila Healthcare Limited		918596198	ANALYSIS(65841-654) , MANUFACTURE(65841-654)