Nortrel 7/7/7 (28 Day Regimen) (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

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Foil Pouch Text

NDC 54868-5286-0


Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets, USP-triphasic regimen)
Each light yellow tablet contains 0.5 mg norethindrone and 0.035 mg ethinyl estradiol. Each blue tablet contains 0.75 mg norethindrone and 0.035 mg ethinyl estradiol. Each peach tablet contains 1 mg norethindrone and 0.035 mg ethinyl estradiol. Each white tablet contains inert ingredients.
28 DAY REGIMEN
Rx only
THIS PRODUCT (LIKE ALL ORAL CONTRACEPTIVES) IS INTENDED TO PREVENT PREGNANCY. IT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.

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NORTREL 7/7/7 (28 DAY REGIMEN) norethindrone and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5286(NDC:0555-9012)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5286-0 1 BLISTER PACK (BLISTER PACK) in 1 POUCH contains a BLISTER PACK
1 1 KIT (KIT) in 1 BLISTER PACK This package is contained within the POUCH (54868-5286-0)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 7
Part 2 7
Part 3 7
Part 4 7
Part 1 of 4
NORTREL 7/7/7 (28 DAY REGIMEN) 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 0.5 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.035 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;951
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075478 08/19/2008
Part 2 of 4
NORTREL 7/7/7 (28 DAY REGIMEN) 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 0.75 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.035 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;942
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075478 08/19/2008
Part 3 of 4
NORTREL 7/7/7 (28 DAY REGIMEN) 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
FD&C YELLOW NO. 6
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color ORANGE (peach) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;943
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075478 08/19/2008
Part 4 of 4
INERT (28 DAY REGIMEN) 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 ROUND Size 6mm
Flavor Imprint Code
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075478 08/19/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075478 08/19/2008
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 06/2012 Physicians Total Care, Inc.

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