Bromocriptine mesylate
Bromocriptine Mesylate Tablets, USP
Approved
Approval ID
0ee2da00-faf8-4c51-a696-9462fa4f6050
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 1, 2022
Manufacturers
FDA
Padagis US LLC
DUNS: 967694121
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 Code0574-0106
Application NumberANDA077646
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bromocriptine mesylate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 12, 2018
FDA Product Classification
INGREDIENTS (7)
BROMOCRIPTINE MESYLATEActive
Quantity: 2.5 mg in 1 1
Code: FFP983J3OD
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALEIC ACIDInactive
Code: 91XW058U2C
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT