Tri-Estarylla (Page 9 of 9)

PRINCIPAL DISPLAY PANEL

NDC 70700-121-85

3 Units (3 x 28 tablet blister card)

Tri- EstaryllaTM ( Norgestimate and Ethinyl Estradiol Tablets, USP)

0.18 mg/0.35 mg, 0.0215 mg/0.35 mg, 0.25 mg/0.35 mg

Rx only

tri-estar-carton
(click image for full-size original)

TRI-ESTARYLLA norgestimate and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70700-121
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70700-121-85 3 CARTON in 1 CARTON contains a CARTON (70700-121-84)
1 NDC:70700-121-84 1 BLISTER PACK in 1 CARTON This package is contained within the CARTON (70700-121-85) and contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within a CARTON (70700-121-84) and a CARTON (70700-121-85)
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
TRI-ESTARYLLA norgestimate and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORGESTIMATE (norgestimate) NORGESTIMATE 0.180 mg
ETHINYL ESTRADIOL (ethinyl estradiol) ETHINYL ESTRADIOL 0.035 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code SZ;T2
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090793 12/20/2018
Part 2 of 4
TRI-ESTARYLLA norgestimate and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORGESTIMATE (norgestimate) NORGESTIMATE 0.215 mg
ETHINYL ESTRADIOL (ethinyl estradiol) ETHINYL ESTRADIOL 0.035 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
FD&C BLUE NO. 2
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color BLUE (light blue) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code SZ;T3
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090793 12/20/2018
Part 3 of 4
TRI-ESTARYLLA norgestimate and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORGESTIMATE (norgestimate) NORGESTIMATE 0.25 mg
ETHINYL ESTRADIOL (ethinyl estradiol) ETHINYL ESTRADIOL 0.035 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
FD&C BLUE NO. 2
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code SZ;T4
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090793 12/20/2018
Part 4 of 4
INERT inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
D&C YELLOW NO. 10
FD&C BLUE NO. 2
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color GREEN Score no score
Shape ROUND Size 6mm
Flavor Imprint Code SZ;J1
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090793 01/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090793 01/01/2018
Labeler — Xiromed, LLC. (080228637)
Registrant — XIROMED PHARMA ESPANA, S.L. (468835741)

Revised: 09/2019 Xiromed, LLC.

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