Norelgestromin And Ethinyl Estradiol Transdermal System

Norelgestromin And Ethinyl Estradiol Transdermal System
SPL v1
SPL
SPL Set ID 7c2cc8ab-db6d-4a1c-ae74-e0ef27e2f3a9
Route
TRANSDERMAL
Published
Effective Date 2023-09-16
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Norelgestromin (150 ug) Ethinyl Estradiol (35 ug)
Inactive Ingredients
Crospovidone Lauryl Lactate

Identifiers & Packaging

Marketing Status
ANDA Active Since 2023-11-21

Description

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 cm 2 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


Medication Information

Description

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 cm 2 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

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


Structured Label Content

Package Label.principal Display Panel (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


Advanced Ingredient Data


Raw Label Data

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