Myzilra (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — Kit Carton

CommUnity Care Federally Qualified Centers

Myzilra

-Triphasic

#28

Date:

Name:

Dr.

TAKE 1 TABLET DAILY AS DIRECTED. (Alternative for Triphasil)

123456

1/1/01

Myzilra Triphasic Regimen #28 Tabs 76413-116-28

Batch: 123456

Lot: 123456

Exp: 1/1/01

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

PRINCIPAL DISPLAY PANEL -- Kit Carton
(click image for full-size original)
MYZILRA levonorgestrel and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76413-116(NDC:0603-7625)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76413-116-28 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 6
Part 2 5
Part 3 10
Part 4 7
Part 1 of 4
MYZILRA levonorgestrel and 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 0.05 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.03 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C YELLOW NO. 6
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
STARCH, CORN
.ALPHA.-TOCOPHEROL ACETATE, DL-
Product Characteristics
Color WHITE (beige) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 93;680
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077502 01/12/2012
Part 2 of 4
MYZILRA levonorgestrel and 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 0.075 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.04 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
STARCH, CORN
.ALPHA.-TOCOPHEROL ACETATE, DL-
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 93;681
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077502 01/12/2012
Part 3 of 4
MYZILRA levonorgestrel and 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 0.125 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.03 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
STARCH, CORN
.ALPHA.-TOCOPHEROL ACETATE, DL-
Product Characteristics
Color YELLOW (light-yellow) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 93;682
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077502 01/12/2012
Part 4 of 4
MYZILRA inert tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2
HYPROMELLOSES
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
STARCH, CORN
Product Characteristics
Color GREEN (light-green) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 93;743
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077502 01/12/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077502 01/12/2012
Labeler — Central Texas Community Health Centers (079674019)
Establishment
Name Address ID/FEI Operations
Central Texas Community Health Centers 079674019 REPACK (76413-116), RELABEL (76413-116)

Revised: 02/2016 Central Texas Community Health Centers

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