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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVONORGESTREL(UNII: 5W7SIA7YZW)
(LEVONORGESTREL - UNII:5W7SIA7YZW) 		LEVONORGESTREL1.5 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52544-287-541 in 1 CARTON 16/07/2012
11 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200670 07/16/2012 08/31/2015

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

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

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PRINCIPAL DISPLAY PANEL

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