Bromocriptine Mesylate
Approved
Approval ID
72d8eefe-c066-41b6-8922-9586f1cf47a1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 13, 2021
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
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 Code0378-7096
Application NumberANDA077226
Product Classification
M
Marketing Category
C73584
G
Generic Name
bromocriptine mesylate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2021
FDA Product Classification
INGREDIENTS (18)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MALEIC ACIDInactive
Code: 91XW058U2C
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BROMOCRIPTINE MESYLATEActive
Quantity: 5 mg in 1 1
Code: FFP983J3OD
Classification: ACTIM
SHELLACInactive
Code: 46N107B71O
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT