Velivet Triphasic Regimen (Page 9 of 9)

Velivet Tablets 28-Day Regimen

Label Image
(click image for full-size original)
VELIVET TRIPHASIC REGIMEN
desogestrel and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53002-1775(NDC:0555-9051)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53002-1775-1 1 KIT in 1 BLISTER PACK None
2 NDC:53002-1775-6 6 BLISTER PACK in 1 POUCH contains a BLISTER PACK
2 1 KIT in 1 BLISTER PACK This package is contained within the POUCH (53002-1775-6)
3 NDC:53002-1775-3 3 BLISTER PACK in 1 POUCH contains a BLISTER PACK
3 1 KIT in 1 BLISTER PACK This package is contained within the POUCH (53002-1775-3)
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
DESOGESTREL AND ETHINYL ESTRADIOL
desogestrel and 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 0.1 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.025 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 8000
POLYSORBATE 80
POVIDONE K30
STARCH, CORN
STEARIC ACID
TITANIUM DIOXIDE
.ALPHA.-TOCOPHEROL
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color BROWN (beige) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;333
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
ANDA ANDA076455 03/01/2004
Part 2 of 4
DESOGESTREL AND ETHINYL ESTRADIOL
desogestrel and ethinyl estradiol tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;332
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
ANDA ANDA076455 03/01/2004
Part 3 of 4
DESOGESTREL AND ETHINYL ESTRADIOL
desogestrel and ethinyl estradiol tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Product Characteristics
Color PINK Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;335
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
ANDA ANDA076455 03/01/2004
Part 4 of 4
INERT
inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;334
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
ANDA ANDA076455 03/01/2004
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076455 03/01/2004
Labeler — RPK Pharmaceuticals, Inc. (147096275)
Establishment
Name Address ID/FEI Operations
RPK Pharmaceuticals, Inc. 147096275 RELABEL (53002-1775)

Revised: 12/2020 RPK Pharmaceuticals, Inc.

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