Norethindrone Acetate: Package Insert and Label Information (Page 2 of 2)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

90 Ct.
(click image for full-size original)

Label 5 mg

NORETHINDRONE ACETATE
norethindrone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-475
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORETHINDRONE ACETATE (NORETHINDRONE) NORETHINDRONE ACETATE 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (off-white) Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code AN;475
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-475-03 30 TABLET in 1 BOTTLE None
2 NDC:65162-475-05 50 TABLET in 1 BOTTLE None
3 NDC:65162-475-09 90 TABLET in 1 BOTTLE None
4 NDC:65162-475-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200275 07/01/2009
Labeler — Amneal Pharmaceuticals of New York, LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals of New York, LLC 831227777 ANALYSIS (65162-475), LABEL (65162-475), MANUFACTURE (65162-475), PACK (65162-475)

Revised: 10/2015 Amneal Pharmaceuticals of New York, LLC

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