NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0378-7288-53

Rx only

Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets*

1.5 mg/0.03 mg

Each blue tablet contains norethindrone acetate 1.5 mg and ethinyl estradiol 0.03 mg.

Each brown tablet contains ferrous fumarate USP, 75 mg.

Each blister pack contains 21 blue tablets and 7 brown tablets.

*Ferrous fumarate tablets are not USP for dissolution and assay.

This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

3 pouches, each pouch contains one blister pack of 28 tablets

DOSAGE: One tablet daily as prescribed. See prescribing information.

IMPORTANT: The “Patient Instructions” which are packaged inside each pouch provides important instructions to the patient. Please supply these instructions and the carrier sleeve to the patient when dispensing.

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

Keep this and all medication out of the reach of children.

3s Carton
(click image for full-size original)
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL norethindrone acetate and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-7288
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-7288-53 3 POUCH in 1 CARTON contains a POUCH (0378-7288-85)
1 NDC:0378-7288-85 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (0378-7288-53) and contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within a POUCH (0378-7288-85) and a CARTON (0378-7288-53)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL norethindrone acetate and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.03 mg
NORETHINDRONE ACETATE (NORETHINDRONE) NORETHINDRONE ACETATE 1.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
.ALPHA.-TOCOPHEROL, DL-
SUCROSE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
FD&C BLUE NO. 1
POVIDONE K25
SODIUM LAURYL SULFATE
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 237
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202741 12/16/2019
Part 2 of 2
FERROUS FUMARATE ferrous fumarate tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FERROUS FUMARATE 75 mg
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K90
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 291
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202741 12/16/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202741 12/16/2019
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 08/2019 Mylan Pharmaceuticals Inc.

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