Bromocriptine mesylate
Bromocriptine Mesylate Capsules, USP
Approved
Approval ID
97e7e051-ff64-4381-a869-6c1c364ad822
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 4, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bromocriptine mesylate
PRODUCT DETAILS
NDC Product Code65841-654
Application NumberANDA078899
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 4, 2022
Generic NameBromocriptine mesylate
INGREDIENTS (18)
BROMOCRIPTINE MESYLATEActive
Quantity: 5 mg in 1 1
Code: FFP983J3OD
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
CARRAGEENANInactive
Code: 5C69YCD2YJ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALEIC ACIDInactive
Code: 91XW058U2C
Classification: IACT