Tri-Lo-Sprintec (Page 7 of 7)

Norgestimate and Ethinyl Estradiol

Label ImageLabel Image
TRI-LO-SPRINTEC
norgestimate and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-2326(NDC:0093-2140)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-2326-0 1 KIT in 1 KIT None
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
NORGESTIMATE AND ETHINYL ESTRADIOL
norgestimate and ethinyl estradiol tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORGESTIMATE (NORGESTIMATE) NORGESTIMATE 0.18 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.025 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
FERROSOFERRIC OXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color GRAY Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;451
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076784 12/30/2015
Part 2 of 4
NORGESTIMATE AND ETHINYL ESTRADIOL
norgestimate and ethinyl estradiol tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2
Product Characteristics
Color BLUE (light blue) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;452
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076784 12/30/2015
Part 3 of 4
NORGESTIMATE AND ETHINYL ESTRADIOL
norgestimate and ethinyl estradiol tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;453
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076784 12/30/2015
Part 4 of 4
INERT
inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2208 (3 MPA.S)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;208
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076784 12/30/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076784 12/30/2015
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-2326)

Revised: 10/2021 A-S Medication Solutions

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2023. All Rights Reserved.