LEVONORGESTREL AND ETHINYL ESTRADIOL

LEVONORGESTREL AND ETHINYL ESTRADIOL — levonorgestrel and ethinyl estradiol
Jai Pharma Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton
(click image for full-size original)
LEVONORGESTREL AND ETHINYL ESTRADIOL
levonorgestrel and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57994-008
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57994-008-90 2 POUCH in 1 CARTON contains a POUCH
1 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (57994-008-90) and contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within a POUCH and a CARTON (57994-008-90)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 84
Part 2 7
Part 1 of 2
LEVONORGESTREL AND ETHINYL ESTRADIOL
levonorgestrel and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVONORGESTREL (LEVONORGESTREL) LEVONORGESTREL 0.1 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.02 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLACRILIN POTASSIUM
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 214
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200493 01/01/2017
Part 2 of 2
ETHINYL ESTRADIOL
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 0.01 mg
Inactive Ingredients
Ingredient Name Strength
.ALPHA.-TOCOPHEROL, DL-
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
FD&C YELLOW NO. 6
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLACRILIN POTASSIUM
POVIDONE K25
Product Characteristics
Color ORANGE (Light Peach) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 215
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200493 01/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200493 01/01/2017
Labeler — Jai Pharma Limited (650882132)
Registrant — Jai Pharma Limited (650882132)
Establishment
Name Address ID/FEI Operations
Jai Pharma Limited 677604150 analysis (57994-008), label (57994-008), manufacture (57994-008), pack (57994-008)

Revised: 09/2016 Jai Pharma Limited

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