MedPath

Cabergoline

Cabergoline Tablets

Approved
Approval ID

e497366b-a124-4d7f-bd45-a883c392d4bb

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 28, 2022

Manufacturers
FDA

Greenstone LLC

DUNS: 825560733

FDA

Mylan Pharmaceuticals Inc.

DUNS: 059295980

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

cabergoline

PRODUCT DETAILS

NDC Product Code59762-1005
Application NumberNDA020664
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateNovember 28, 2022
Generic Namecabergoline

INGREDIENTS (3)

CABERGOLINEActive
Quantity: 0.5 mg in 1 1
Code: LL60K9J05T
Classification: ACTIB
LEUCINEInactive
Code: GMW67QNF9C
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/28/2022

PRINCIPAL DISPLAY PANEL - 8 Tablet Bottle Carton

NDC 59762-1005-1
8 Tablets

GREENSTONE**®**** BRAND**

cabergoline
tablets

0.5 mg

Rx only

PRINCIPAL DISPLAY PANEL - 8 Tablet Bottle Carton

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 11/28/2022

Rx only

This product's label may have been updated. For current full prescribing information, please visit www.Greenstonellc.com

Logo

LAB-0304-8.0
Revised: November 2019

DESCRIPTION SECTION

LOINC: 34089-3Updated: 11/28/2022

DESCRIPTION

CABERGOLINE tablets contain cabergoline, a dopamine receptor agonist. The chemical name for cabergoline is 1-[(6-allylergolin-8β-yl)-carbonyl]-1-[3-(dimethylamino) propyl]-3-ethylurea. Its empirical formula is C26H37N5O2, and its molecular weight is 451.62. The structural formula is as follows:

Chemical Structure

Cabergoline is a white powder soluble in ethyl alcohol, chloroform, and N, N-dimethylformamide (DMF); slightly soluble in 0.1N hydrochloric acid; very slightly soluble in n-hexane; and insoluble in water.

Cabergoline tablets, for oral administration, contain 0.5 mg of cabergoline. Inactive ingredients consist of leucine, USP, and lactose, NF.

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