OVCON 35 (Page 6 of 6)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

OVCON 35 Carton
(click image for full-size original)

3 Blister Cards of 28 Tablets Each.

N 0430-0580-45

28 day 0.4/35 OVCON® 35
(Norethindrone and Ethinyl Estradiol Tablets, USP)

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

Rx only

Warner Chilcott

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

Three PATIENT INSERTS are enclosed for your use when dispensing OVCON® 35.

Additional copies are available from Warner Chilcott (US), LLC
100 Enterprise Drive
Rockaway, NJ 07866

See bottom flap for lot number and expiration date

Each of the 21 LIGHT PEACH tablets contains
0.4 mg norethindrone
and 0.035 mg ethinyl estradiol.
Each of the 7 WHITE tablets contains inert ingredients.

Dosage: 1 tablet daily as prescribed. See Package Insert enclosed for complete Prescribing Information.

OVCON 35 norethindrone and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0430-0580
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0430-0580-14 72 CARTON (CARTON) in 1 CASE contains a CARTON
1 5 CELLO PACK (CELLO PACK) in 1 CARTON This package is contained within the CASE (0430-0580-14) and contains a CELLO PACK
1 1 BLISTER PACK (BLISTER PACK) in 1 CELLO PACK This package is contained within the CARTON and contains a BLISTER PACK
1 1 KIT (KIT) in 1 BLISTER PACK This package is contained within a CELLO PACK and a CARTON and a CASE (0430-0580-14)
2 NDC:0430-0580-45 72 CARTON (CARTON) in 1 CASE contains a CARTON
2 3 CELLO PACK (CELLO PACK) in 1 CARTON This package is contained within the CASE (0430-0580-45) and contains a CELLO PACK
2 1 BLISTER PACK (BLISTER PACK) in 1 CELLO PACK This package is contained within the CARTON and contains a BLISTER PACK
2 1 KIT (KIT) in 1 BLISTER PACK This package is contained within a CELLO PACK and a CARTON and a CASE (0430-0580-45)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
OVCON 35 norethindrone and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORETHINDRONE (NORETHINDRONE) NORETHINDRONE 1 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.035 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
FD&C YELLOW NO. 6
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color ORANGE (Light Peach) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code WC;580
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076238 06/01/2005
Part 2 of 2
INERT inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 7mm
Flavor Imprint Code WC;781
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076238 06/01/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076238 06/01/2005
Labeler — Warner Chilcott (US), LLC (957203177)
Establishment
Name Address ID/FEI Operations
Barr Laboratories Inc. 824749340 MANUFACTURE, ANALYSIS
Establishment
Name Address ID/FEI Operations
Duramed Pharmaceuticals Inc. 017038951 MANUFACTURE, ANALYSIS

Revised: 04/2009 Warner Chilcott (US), LLC

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.