Tri-Sprintec (Page 9 of 9)

Package/Label Display Panel

Tri-Sprintec® 28 Day Regimen Carton
(click image for full-size original)

Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) Carton Text

NDC 0555-9018 -58

6 Blister Cards, 28 Tablets Each 28 Day

Tri-Sprintec®

(norgestimate and
ethinyl estradiol tablets USP)

Usual Dosage: One tablet daily for 28 consecutive days per menstrual

cycle as prescribed. See enclosed package insert for full prescribing

information.

To the Dispenser: This carton contains one combination labeling piece

of information intended for the patient. Informational pieces are to be

provided to the patient with each prescription.

Rx only

Shaping
Women’s Health┬«

TEVA

TRI-SPRINTEC
norgestimate and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0555-9018
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0555-9018-58 6 POUCH in 1 CARTON contains a POUCH
1 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (0555-9018-58) and contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within a POUCH and a CARTON (0555-9018-58)
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-SPRINTEC
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 0.18 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.035 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
LACTOSE MONOHYDRATE
ALUMINUM OXIDE
ALUMINUM SULFATE
ALUMINUM CHLORIDE
FD&C BLUE NO. 2
INDIGOTINDISULFONATE SODIUM
FD&C RED NO. 40
FD&C YELLOW NO. 6
SODIUM BICARBONATE
SODIUM CARBONATE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color GRAY Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;985
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075808 12/29/2003
Part 2 of 4
TRI-SPRINTEC
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
ANHYDROUS LACTOSE
FD&C BLUE NO. 2
INDIGOTINDISULFONATE SODIUM
ALUMINUM OXIDE
ALUMINUM SULFATE
ALUMINUM CHLORIDE
SODIUM BICARBONATE
SODIUM CARBONATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color BLUE (light blue) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;986
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075808 12/29/2003
Part 3 of 4
TRI-SPRINTEC
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
ANHYDROUS LACTOSE
FD&C BLUE NO. 2
INDIGOTINDISULFONATE SODIUM
ALUMINUM OXIDE
ALUMINUM SULFATE
ALUMINUM CHLORIDE
SODIUM BICARBONATE
SODIUM CARBONATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;987
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075808 12/29/2003
Part 4 of 4
INERT
inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
HYPROMELLOSE 2208 (3 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;143
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075808 12/29/2003
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075808 12/29/2003
Labeler — Barr Laboratories Inc. (802716563)

Revised: 06/2015 Barr Laboratories Inc.

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