Bromocriptine Mesylate
Bromocriptine Mesylate Tablets, USP Rx Only Prescribing Information
Approved
Approval ID
2d04778c-ec3f-6a61-e063-6294a90ae449
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 27, 2025
Manufacturers
FDA
Bionpharma Inc.
DUNS: 079637826
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 Code69452-476
Application NumberNDA017962
Product Classification
M
Marketing Category
C73594
G
Generic Name
Bromocriptine Mesylate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 27, 2025
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALEIC ACIDInactive
Code: 91XW058U2C
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
BROMOCRIPTINE MESYLATEActive
Quantity: 2.5 mg in 1 1
Code: FFP983J3OD
Classification: ACTIM