Azurette (Page 10 of 10)

Azurette Tablets 28-Day Regimen

Label Image
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AZURETTE desogestrel/ethinyl estradiol and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53002-1600(NDC:51862-072)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53002-1600-6 6 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the PACKAGE (53002-1600-6)
2 NDC:53002-1600-3 3 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK
2 1 KIT in 1 BLISTER PACK This package is contained within the PACKAGE (53002-1600-3)
3 NDC:53002-1600-1 1 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK
3 1 KIT in 1 BLISTER PACK This package is contained within the PACKAGE (53002-1600-1)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 2
Part 3 5
Part 1 of 3
DESOGESTREL/ETHINYL ESTRADIOL desogestrel/ethinyl estradiol tablet, film coated
Product Information
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 0.02 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 8000
POVIDONE K30
STARCH, CORN
STEARIC ACID
.ALPHA.-TOCOPHEROL
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code dp;021
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075863 11/14/2016
Part 2 of 3
INERT inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color GREEN (light-green) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code dp;331
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075863 11/14/2016
Part 3 of 3
ETHINYL ESTRADIOL ethinyl estradiol tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2
INDIGOTINDISULFONATE SODIUM
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (50 MPA.S)
POLYDEXTROSE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color BLUE (light-blue) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code dp;022
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075863 11/14/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075863 11/14/2016
Labeler — RPK Pharmaceuticals, Inc. (147096275)
Establishment
Name Address ID/FEI Operations
RPK Pharmaceuticals, Inc. 147096275 RELABEL (53002-1600), REPACK (53002-1600)

Revised: 12/2020 RPK Pharmaceuticals, Inc.

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