Isibloom (Page 7 of 7)

Principal Display Panel

NDC 70700-113-85

Isibloom (Desogestrel and Ethinyl Estradiol Tablets, USP)

0.15 mg/0.03 mg

Rx Only

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ISIBLOOM desogestrel and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70700-113
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70700-113-85 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (70700-113-85)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
DESOGESTREL AND ETHINYL ESTRADIOL desogestrel and ethinyl estradiol tablet
Product Information
Item Code (Source) NDC:70700-813
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESOGESTREL (DESOGESTREL) DESOGESTREL 0.15 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.03 mg
Inactive Ingredients
Ingredient Name Strength
.ALPHA.-TOCOPHEROL
STARCH, CORN
POVIDONE K30
STEARIC ACID
SILICON DIOXIDE
LACTOSE MONOHYDRATE
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
HYPROMELLOSE 2910 (15 MPA.S)
POLYSORBATE 80
FERRIC OXIDE RED
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color ORANGE Score no score
Shape ROUND (Round) Size 5mm
Flavor Imprint Code SZ;D2;
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202789 02/01/2018
Part 2 of 2
REMINDER inert tablet, coated
Product Information
Item Code (Source) NDC:70700-814
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
POVIDONE K30
SILICON DIOXIDE
MAGNESIUM STEARATE
FD&C BLUE NO. 2
HYPROMELLOSE 2910 (15 MPA.S)
POLYSORBATE 80
TITANIUM DIOXIDE
TRIACETIN
FERRIC OXIDE YELLOW
Product Characteristics
Color GREEN (green) Score no score
Shape ROUND Size 5mm
Flavor Imprint Code SZ;J1
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202789 02/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202789 02/01/2018
Labeler — Xiromed, LLC. (080228637)
Registrant — XIROMED PHARMA ESPANA, S.L. ( (468835741)

Revised: 02/2023 Xiromed, LLC.

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