MedPath

Cabergoline

Cabergoline Tablets USP Rx only

Approved
Approval ID

c9f0b576-d5e5-4e3e-bb5c-3574d75d9907

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 16, 2021

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 Code50090-3157
Application NumberANDA077750
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cabergoline
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2020
FDA Product Classification

INGREDIENTS (3)

CABERGOLINEActive
Quantity: 0.5 mg in 1 1
Code: LL60K9J05T
Classification: ACTIB
LEUCINEInactive
Code: GMW67QNF9C
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT

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Cabergoline - FDA Drug Approval Details