NORELGESTROMIN AND ETHINYL ESTRADIOL patch

norelgestromin and ethinyl estradiol by

Drug Labeling and Warnings

norelgestromin and ethinyl estradiol by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

NORELGESTROMIN AND ETHINYL ESTRADIOL 
norelgestromin and ethinyl estradiol patch

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1777
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NORELGESTROMIN (UNII: R0TAY3X631) (NORELGESTROMIN - UNII:R0TAY3X631)	NORELGESTROMIN	150 ug  in 1 mg
ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)	ETHINYL ESTRADIOL	35 ug  in 1 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (UNII: 2S7830E561)
LAURYL LACTATE (UNII: G5SU0BFK7O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1777-3	3 in 1 CARTON	11/21/2023
1	NDC: 70771-1777-1	1 in 1 POUCH
1		7 mg in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA214594	11/21/2023

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1777) , MANUFACTURE(70771-1777)