BROMOCRIPTINE MESYLATE - bromocriptine mesylate capsule 
Zydus Lifesciences Limited

----------

Bromocriptine Mesylate Capsules, USP

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 capsules, 5 mg
BROMOCRIPTINE MESYLATE 
bromocriptine mesylate capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-654
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMOCRIPTINE MESYLATE (UNII: FFP983J3OD) (BROMOCRIPTINE - UNII:3A64E3G5ZO) BROMOCRIPTINE5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorBROWN (TAN) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size16mm
FlavorImprint Code ZA17;5mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-654-0630 in 1 BOTTLE; Type 0: Not a Combination Product01/23/2009
2NDC:65841-654-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/23/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07889901/23/2009
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-654) , MANUFACTURE(65841-654)

Revised: 8/2022
Document Id: 7e314671-fe6e-4ad9-b25a-f6fe1ca2109f
Set id: 97e7e051-ff64-4381-a869-6c1c364ad822
Version: 9
Effective Time: 20220804
 
Zydus Lifesciences Limited