Jolessa (Page 8 of 8)

Jolessa 0.15mg/0.03mg Tablets 91-Day Regimen

Label Image
(click image for full-size original)
JOLESSA
levonorgestrel / ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53002-1779(NDC:0555-9123)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53002-1779-1 1 KIT in 1 BLISTER PACK None
2 NDC:53002-1779-3 3 BLISTER PACK in 1 POUCH contains a BLISTER PACK
2 1 KIT in 1 BLISTER PACK This package is contained within the POUCH (53002-1779-3)
3 NDC:53002-1779-6 6 BLISTER PACK in 1 POUCH contains a BLISTER PACK
3 1 KIT in 1 BLISTER PACK This package is contained within the POUCH (53002-1779-6)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 84
Part 2 7
Part 1 of 2
LEVONORGESTREL/ETHINYL ESTRADIOL
levonorgestrel/ethinyl estradiol tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVONORGESTREL (LEVONORGESTREL) LEVONORGESTREL 0.15 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.03 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
FD&C BLUE NO. 1
FD&C RED NO. 40
HYPROMELLOSE 2208 (3 MPA.S)
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
MAGNESIUM STEARATE
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color PINK Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;992
Contains
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA021544 10/13/2003
Part 2 of 2
INERT
inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;208
Contains
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA021544 10/13/2003
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA021544 10/13/2003
Labeler — RPK Pharmaceuticals, Inc. (147096275)
Establishment
Name Address ID/FEI Operations
RPK Pharmaceuticals, Inc. 147096275 RELABEL (53002-1779)

Revised: 12/2020 RPK Pharmaceuticals, Inc.

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