NDC Code 52544-287-54 - Levonorgestrel

NDC Code(s) : 52544-287-54
Packager : Actavis Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LevonorgestrelNext Choice One Dose TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:52544-287
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVONORGESTREL(UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)	LEVONORGESTREL	1.5 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)

Product Characteristics
Color	ORANGE (peach)	Score	no score
Shape	ROUND	Size	6 mm
Flavor		Imprint Code	WATSON;287
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52544-287-54	1 in 1 CARTON	16/07/2012
1		1 in 1 BLISTER PACK Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA200670	07/16/2012	08/31/2015

PRINCIPAL DISPLAY PANEL

NDC 52544-287-54
New! Now only ONE dose
Next Choice ONE DOSE^TM
(Levonorgestrel) Tablet 1.5 mg
Emergency Contraceptive
One Tablet One Dose
1 Levonorgestrel Tablet 1.5 mg
Rx only for women younger than 17

NextChoicefront carton label