Yaz (Page 10 of 10)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

YAZ Individual Trade Carton

NDC 50419-405-01 1 Unit

Rx only

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

YAZ®

(drospirenone & ethinyl estradiol)

3 mg /0.02 mg

28 tablets

oral

Carton
(click image for full-size original)
YAZ drospirenone and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50419-405
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50419-405-03 3 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the PACKAGE (50419-405-03)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 24
Part 2 4
Part 1 of 2
YAZ 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 0.02 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
FERRIC OXIDE RED
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color PINK Score no score
Shape 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 NDA021676 03/16/2006
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 Score no score
Shape 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 NDA021676 03/11/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021676 03/16/2006
Labeler — Bayer HealthCare Pharmaceuticals Inc. (005436809)
Establishment
Name Address ID/FEI Operations
Bayer Weimar GmbH und Co. KG 331485631 MANUFACTURE (50419-405), ANALYSIS (50419-405)
Establishment
Name Address ID/FEI Operations
Bayer AG 315097875 PACK (50419-405), LABEL (50419-405)
Establishment
Name Address ID/FEI Operations
Sharp Corporation 143696495 LABEL (50419-405)
Establishment
Name Address ID/FEI Operations
Bayer AG 314398484 API MANUFACTURE (50419-405), ANALYSIS (50419-405)
Establishment
Name Address ID/FEI Operations
Bayer AG 342872971 PARTICLE SIZE REDUCTION (50419-405), ANALYSIS (50419-405)

Revised: 05/2023 Bayer HealthCare Pharmaceuticals Inc.

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