Cabergoline
CABERGOLINE TABLETS, USPRx only
Approved
Approval ID
bc44d11b-b3f0-4e3d-9da3-4f8852d11734
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 27, 2023
Manufacturers
FDA
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
DUNS: 780779901
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 Code23155-823
Application NumberANDA076310
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cabergoline
Product Specifications
Route of AdministrationORAL
Effective DateJune 17, 2022
FDA Product Classification
INGREDIENTS (5)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CABERGOLINEActive
Quantity: 0.5 mg in 1 1
Code: LL60K9J05T
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT