NDC Code(s) : 52125-021-02
Packager : REMEDYREPACK 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:52125-021
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
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE K30(UNII: U725QWY32X)
STARCH, CORN(UNII: O8232NY3SJ)
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000)(UNII: 0K9R94573C)
ACACIA ANGUSTISSIMA BARK(UNII: ID3K20OAXF)
METHYLPARABEN SODIUM(UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM(UNII: 625NNB0G9N)
TARTARIC ACID, D-(UNII: RRX6A4PL3C)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color white Score no score
Shape ROUND (TABLET) Size 4 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-021-0230 in 1 BLISTER PACK Type 0: Not a Combination Product22/07/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091577 07/22/2012 07/23/2013

PRINCIPAL DISPLAY PANEL

DRUG: Methylergonovine Maleate

GENERIC: Methylergonovine Maleate

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 52125-021-02

STRENGTH:0.2 mg

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 4 mm

IMPRINT: 30

QTY: 30



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