NDC Code(s) : 51285-124-88, 51285-146-19
Packager : Teva Women's Health, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Plan B One-StepLevonorgestrel TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51285-124
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, POTATO(UNII: 8I089SAH3T)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TALC(UNII: 7SEV7J4R1U)
STARCH, CORN(UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code G00
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51285-124-881 in 1 BOX, UNIT-DOSE 01/11/2013
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
NDA NDA021998 11/01/2013 06/30/2017
Plan B One-StepLevonorgestrel TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51285-146
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, POTATO(UNII: 8I089SAH3T)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TALC(UNII: 7SEV7J4R1U)
STARCH, CORN(UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code G00
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51285-146-191 in 1 BOX, UNIT-DOSE 18/12/2013
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
NDA NDA021998 12/18/2013

PRINCIPAL DISPLAY PANEL

Plan B One-Step® (levonorgestrel 1.5 mg), 1s Unit-Dose Box, Part 1 of 3

PRINCIPAL DISPLAY PANEL

Plan B One-Step® (levonorgestrel 1.5 mg), 1s Unit-Dose Box, Part 2 of 3

PRINCIPAL DISPLAY PANEL

Plan B One-Step® (levonorgestrel 1.5 mg), 1s Unit-Dose Box, Part 3 of 3

PRINCIPAL DISPLAY PANEL

Plan B One-Step® (levonorgestrel 1.5 mg), 1s CLINIC Unit-Dose Box, Part 1 of 3

PRINCIPAL DISPLAY PANEL

Plan B One-Step® (levonorgestrel 1.5 mg), 1s CLINIC Unit-Dose Box, Part 2 of 3

PRINCIPAL DISPLAY PANEL

Plan B One-Step® (levonorgestrel 1.5 mg), 1s CLINIC Unit-Dose Box, Part 3 of 3