norelgestromin and ethinyl estradiol NORELGESTROMIN AND ETHINYL ESTRADIOL ZYDUS LIFESCIENCES LIMITED FDA Approved No description available yet.
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Substance Ethinyl Estradiol
Route
TRANSDERMAL
Applications
ANDA214594

Drug Facts

Composition & Profile

Identifiers & Packaging

Container Type BOX
UNII
423D2T571U R0TAY3X631
Packaging

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 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 carton

Package Descriptions
  • 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 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 carton