Yasmin (Page 8 of 8)

Package/Label Principal Display Panel

NDC 50419-402-01

1 Unit

YASMIN

(drospirenone and ethinyl estradiol tablets) 3 mg/0.03 mg

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

Store at 25°C with excursions permitted between15–30°C. [See USP Controlled Room Temperature].

To the Dispenser: This unit contains two pieces of information intended for the patient, which are combined in a single booklet. This informational piece is to be provided to the patient with eachprescription.

Rx only

Yasmin Carton
(click image for full-size original)
YASMIN drospirenone and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50419-402
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50419-402-03 3 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the PACKAGE (50419-402-03)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
YASMIN drospirenone and ethinyl estradiol 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
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
FERRIC OXIDE YELLOW
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL 6000
MAGNESIUM STEARATE
POVIDONE K25
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (YELLOW) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code
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 NDA021098 05/11/2001
Part 2 of 2
INERT inert tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (WHITE) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code
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 NDA021098 02/13/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021098 05/11/2001
Labeler — Bayer HealthCare Pharmaceuticals Inc. (005436809)
Establishment
Name Address ID/FEI Operations
Bayer Weimar GmbH und Co. KG 331485631 MANUFACTURE (50419-402)

Revised: 08/2017 Bayer HealthCare Pharmaceuticals Inc.

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