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)

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