NDC Code(s) : 43063-329-01, 43063-329-03, 43063-329-04, 43063-329-06, 43063-329-08, 43063-329-09, 43063-329-10, 43063-329-12, 43063-329-20
Packager : PD-Rx Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

methylergonovine maleatemethylergonovine maleate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-329(NDC:63704-006)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLERGONOVINE MALEATE(UNII: IR84JPZ1RK)
(METHYLERGONOVINE - UNII:W53L6FE61V) 		METHYLERGONOVINE MALEATE0.2 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA(UNII: 5C5403N26O)
STARCH, CORN(UNII: O8232NY3SJ)
GELATIN(UNII: 2G86QN327L)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
METHYLPARABEN(UNII: A2I8C7HI9T)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE(UNII: FZ989GH94E)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
STEARIC ACID(UNII: 4ELV7Z65AP)
TARTARIC ACID(UNII: W4888I119H)
Product Characteristics
Color white Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code N;01
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43063-329-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/08/2011
2NDC:43063-329-033 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/08/2011
3NDC:43063-329-044 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/08/2011
4NDC:43063-329-066 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/08/2011
5NDC:43063-329-088 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/08/2011
6NDC:43063-329-099 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/08/2011
7NDC:43063-329-1010 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/08/2011
8NDC:43063-329-1212 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/08/2011
9NDC:43063-329-2020 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/08/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091577 08/01/2011

PRINCIPAL DISPLAY PANEL

Methylergonovine
Maleate
Tablets, USP

0.2 mg

Rx Only

43063329 Label