Cryselle (Page 5 of 5)

Cryselle Tablets 28-Day Regimen

Label Image
(click image for full-size original)
CRYSELLE
norgestrel and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53002-1188(NDC:0555-9049)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53002-1188-1 1 KIT in 1 BLISTER PACK None
2 NDC:53002-1188-3 3 BLISTER PACK in 1 POUCH contains a BLISTER PACK
2 1 KIT in 1 BLISTER PACK This package is contained within the POUCH (53002-1188-3)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
NORGESTREL AND ETHINYL ESTRADIOL
norgestrel and ethinyl estradiol tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORGESTREL (NORGESTREL) NORGESTREL 0.3 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.03 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 8000
STARCH, CORN
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code dp;543
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075840 07/24/2002
Part 2 of 2
INERT
inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C BLUE NO. 1 ALUMINUM LAKE
FD&C YELLOW NO. 6
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 ANDA075840 07/24/2002
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075840 07/24/2002
Labeler — RPK Pharmaceuticals, Inc. (147096275)
Establishment
Name Address ID/FEI Operations
RPK Pharmaceuticals, Inc. 147096275 RELABEL (53002-1188)

Revised: 06/2023 RPK Pharmaceuticals, Inc.

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 © 2024. All Rights Reserved.