Norethindrone Acetate (Page 3 of 3)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AvKARE ®
NDC 42291-650-90
Norethindrone

Acetate

Tablets, USP
5 mg
ORALLY ACTIVE PROGESTIN
90 Tablets Rx Only

Pharmacist: Dispense the accompanying PATIENT
INFORMATION leaflet to each patient.


Each tablet contains 5 mg norethindrone acetate,
USP.


Usual Dosage: See package insert for full
prescribing information.


Store at 20° to 25°C (68° to 77°F) [See USP
Controlled Room Temperature].


Dispense in a tight, light-resistant container as
defined in the USP, with a child-resistant closure
(as required).


KEEP THIS AND ALL MEDICATIONS OUT OF THE
REACH OF CHILDREN.


Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478 Mfg. Rev. 09-2015-00 AV Rev. 05/17 (P)

Label 1
(click image for full-size original)
NORETHINDRONE ACETATE norethindrone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-650(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
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:42291-650-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200275 06/18/2013
Labeler — AvKARE (796560394)

Revised: 01/2022 AvKARE

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