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Cabergoline

Cabergoline Tablets

Approved
Approval ID

c85d676c-e23e-468d-9de3-79202d9fad3f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 18, 2020

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 Code50090-3951
Application NumberANDA076310
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cabergoline
Product Specifications
Route of AdministrationORAL
Effective DateNovember 12, 2019
FDA Product Classification

INGREDIENTS (5)

CABERGOLINEActive
Quantity: 0.5 mg in 1 1
Code: LL60K9J05T
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

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Cabergoline - FDA Drug Approval Details