NDC Code(s) : 0574-0106-03, 0574-0106-01
Packager : Padagis US LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bromocriptine mesylateBromocriptine mesylate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0574-0106
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMOCRIPTINE MESYLATE(UNII: FFP983J3OD)
(BROMOCRIPTINE - UNII:3A64E3G5ZO) 		BROMOCRIPTINE2.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MALEIC ACID(UNII: 91XW058U2C)
POVIDONE K25(UNII: K0KQV10C35)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color WHITE (White to off-white) Score 2 pieces
Shape ROUND (bevel edged) Size 8 mm
Flavor Imprint Code PAD;0106
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0574-0106-0330 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product04/01/2014
2NDC:0574-0106-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product04/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077646 04/01/2014

LABELER - Padagis US LLC(967694121)

PRINCIPAL DISPLAY PANEL

NDC 0574-0106-03

Rx Only

Bromocriptine Mesylate Tablets, USP 2.5 mg*

30 Tablets

label

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

label