NDC Code(s) : 0378-2800-26
Packager : Mylan Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cabergolinecabergoline TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-2800
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CABERGOLINE(UNII: LL60K9J05T)
(CABERGOLINE - UNII:LL60K9J05T) 		CABERGOLINE0.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
LEUCINE(UNII: GMW67QNF9C)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape OVAL Size 8 mm
Flavor Imprint Code M;C;G
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-2800-268 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/12/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202947 12/02/2013 08/31/2015

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 0.5 mg

NDC 0378-2800-26

Cabergoline
Tablets, USP

0.5 mg

Rx only     8 Tablets

Each tablet contains:
Cabergoline, USP           0.5 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Usual Dosage: See accompanying
prescribing information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RM2800CF1

Cabergoline Tablets, USP 0.5 mg Bottle Label