Cabergoline
Cabergoline Tablets, USP
Approved
Approval ID
89ec147b-a6fe-49bb-9af5-52fc2ce5db7f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 12, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-5834
Application NumberANDA204735
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cabergoline
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2019
FDA Product Classification
INGREDIENTS (5)
CABERGOLINEActive
Quantity: 0.5 mg in 1 1
Code: LL60K9J05T
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT