Safyral (Page 10 of 10)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

SAFYRAL Trade Carton

NDA 50419-403-01

1 Unit

Rx only

This product (like all oral contraceptives) in intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

SAFYRAL™

(drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets)

3mg/0.03 mg/0.451 mg and 0.451 mg

28 tablets

Oral

Serialized Cartob
(click image for full-size original)
SAFYRAL drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50419-403
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50419-403-00 90 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the PACKAGE (50419-403-00)
2 NDC:50419-403-03 3 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK (50419-403-01)
2 NDC:50419-403-01 1 KIT in 1 BLISTER PACK This package is contained within the PACKAGE (50419-403-03)
3 NDC:50419-403-75 12 PACKAGE in 1 CARTON contains a PACKAGE
3 5 BLISTER PACK in 1 PACKAGE This package is contained within the CARTON (50419-403-75) and contains a BLISTER PACK (50419-403-71)
3 NDC:50419-403-71 1 KIT in 1 BLISTER PACK This package is contained within a PACKAGE and a CARTON (50419-403-75)
4 NDC:50419-403-70 90 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK
4 1 KIT in 1 BLISTER PACK This package is contained within the PACKAGE (50419-403-70)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
SAFYRAL drospirenone/ ethinyl estradiol/ levomefolate calcium tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DROSPIRENONE (DROSPIRENONE) DROSPIRENONE 3 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.03 mg
LEVOMEFOLATE CALCIUM (LEVOMEFOLIC ACID) LEVOMEFOLIC ACID 0.451 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
BETADEX
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
FERRIC OXIDE RED
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code Y
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
NDA NDA022574 02/13/2012
Part 2 of 2
SAFYRAL levomefolate calcium tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOMEFOLATE CALCIUM (LEVOMEFOLIC ACID) LEVOMEFOLIC ACID 0.451 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
POLYETHYLENE GLYCOL, UNSPECIFIED
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color ORANGE (Light) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code M
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
NDA NDA022574 02/13/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022574 02/13/2012
Labeler — Bayer HealthCare Pharmaceuticals Inc. (005436809)
Establishment
Name Address ID/FEI Operations
Bayer Weimar GmbH und Co. KG 331485631 MANUFACTURE (50419-403)
Establishment
Name Address ID/FEI Operations
Bayer AG 315097875 ANALYSIS (50419-403), API MANUFACTURE (50419-403), LABEL (50419-403), MANUFACTURE (50419-403), PACK (50419-403), STERILIZE (50419-403)

Revised: 08/2017 Bayer HealthCare 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 © 2020. All Rights Reserved.