NORELGESTROMIN AND ETHINYL ESTRADIOL- norelgestromin and ethinyl estradiol patch 
Zydus Lifesciences Limited

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NORELGESTROMIN AND ETHINYL ESTRADIOL transdermal system

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1777-3

Norelgestromin and Ethinyl Estradiol Transdermal System 150/35 mcg per day 

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

For Transdermal Use Only 

Contents: 3 Transdermal Systems

Rx only 

Each 15.75 cm2 system contains 4.678 mg norelgestromin, USP and 0.53 mg ethinyl estradiol, USP. The inactive components are polyisobutylene/polybutene adhesive, crospovidone, lauryl lactate, non-woven polyester fabric, polyester backing film laminate and polyester release liner.

See patient instructions. Apply immediately upon removal from pouch. Each transdermal system is intended to be worn 7 days as prescribed.

Package not child-resistant. Keep out of reach of children.

Do not store unpouched. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] 

Manufactured by:

Zydus Lifesciences Ltd.

Ahmedabad, India

Distributed by:

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Rev.: 10/22

carton
NORELGESTROMIN AND ETHINYL ESTRADIOL 
norelgestromin and ethinyl estradiol patch
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1777
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NORELGESTROMIN (UNII: R0TAY3X631) (NORELGESTROMIN - UNII:R0TAY3X631) NORELGESTROMIN150 ug  in 1 mg
ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U) ETHINYL ESTRADIOL35 ug  in 1 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (UNII: 2S7830E561)  
LAURYL LACTATE (UNII: G5SU0BFK7O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1777-33 in 1 CARTON11/21/2023
1NDC:70771-1777-11 in 1 POUCH
17 mg in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21459411/21/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1777) , MANUFACTURE(70771-1777)

Revised: 9/2023
Document Id: 7b3c94ab-6f2b-494f-905f-35f06ff91d14
Set id: 7c2cc8ab-db6d-4a1c-ae74-e0ef27e2f3a9
Version: 1
Effective Time: 20230916
 
Zydus Lifesciences Limited