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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-654
Application NumberANDA078899
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bromocriptine mesylate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 4, 2022
FDA Product Classification
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