Cabergoline
CABERGOLINE TABLETS Rx only
Approved
Approval ID
275a6a25-c3c9-4258-a610-0b00752517f7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 15, 2023
Manufacturers
FDA
SOLA Pharmaceuticals, LLC
DUNS: 080121345
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
cabergoline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70512-860
Application NumberANDA076310
Product Classification
M
Marketing Category
C73584
G
Generic Name
cabergoline
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2023
FDA Product Classification
INGREDIENTS (5)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CABERGOLINEActive
Quantity: 0.5 mg in 1 1
Code: LL60K9J05T
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT