FDA.reportPublic FDA data

NORELGESTROMIN AND ETHINYL ESTRADIOL transdermal system

Manufacturer
Zydus Lifesciences Limited
Effective date
2026-04-16
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:15:23

Label at a glance#

Productnorelgestromin and ethinyl estradiol
Active ingredientNORELGESTROMIN, ETHINYL ESTRADIOL
Label structure1 sections

Label contents#

Full prescribing information#

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

carton
carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1534809norelgestromin 150 MCG / ethinyl estradiol 35 MCG/Day Weekly Transdermal SystemPSN2
1534809168 HR ethinyl estradiol 0.00146 MG/HR / norelgestromin 0.00625 MG/HR Transdermal SystemSCD2
1534809ethinyl estradiol 35 MCG / norelgestromin 150 MCG per 24HR 7 Day Transdermal PatchSY2
1534809norelgestromin 150 MCG / ethinyl estradiol 35 MCG/Day Weekly Transdermal SystemSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ETHINYL ESTRADIOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
NORELGESTROMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11Product name420250623
d39a542a-f5b0-4c2d-a820-0f5d39e6621fProduct name120250307
8511fc19-172b-4e1f-90ec-2f09c85b16deProduct name220250116
d9a998ac-31a9-4391-9054-c30e50912603Product name220240829
782f1593-b73e-4d35-8017-647969d714d8Product name420240805
1a545a57-aed5-4b6e-b1f9-a93c26d50effProduct name120230829
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50Product name320230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689Product name520230627
0d9f32e2-f85b-4d63-9f04-b06059c34749Product name320230323
fa479cfe-0bd0-7366-d57a-92f3682e87c5Product name320210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9Product name320210513
cec4644c-0fed-4608-a5ea-d3a1b1b6d697Product name220200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424Product name620200716
5956a0e2-c373-452c-bdcf-c93d354432efProduct name120200714
ca306105-d51c-4821-9ec1-8eec753d073dProduct name120200619
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9Product name820200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6Product name820191120
6dd982ab-2966-22ee-3b75-d225abb791aaProduct name520190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
60ff9adc-7870-42ca-8836-514bd9732fa8Product name420181220
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
c6636356-4ccb-40e9-a952-59eb1f2fc859Product name420180806
79d5025d-8129-440a-b861-6df2d2661609Product name320180607
e042bc86-5d40-8945-82f8-de9dd95420ddProduct name620180606
d871c48c-6b0b-4203-b55d-72ead21ea7adProduct name520180419
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
390e6d23-3a11-4327-9294-c958a378baaeProduct name420180124
12434b90-2738-45d5-9e1b-55001e853273Product name220171122
b651f154-0364-4007-9dc6-9d33036db1d7Product name420170808
3395ac9b-f30b-4991-80ba-fd5196be0214Product name320170802
2d386545-84d1-e1e9-1402-7fc8962353e8Product name220170717
a5e2d962-d98c-4fbf-8183-ffd42dd01e19Product name620170711
30783b73-16b0-4cc1-b03a-e5d801c0d7a8Product name420170608
00606b81-6e33-4c38-9ca9-bd14bd74d84cProduct name420170501
f4ce24e8-8632-4fad-9984-b693f985f80fProduct name320170501
b17c5419-b38b-579f-10bc-8a4ce69fc044Product name520170316
120cc5ad-761c-444c-9e82-dec22f96dfe1Product name720161219
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
5e13e814-349e-3480-99f3-ee22a591426fProduct name220150518
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1777-1norelgestromin and ethinyl estradiol1 in 1 POUCHPATCH12
70771-1777-1norelgestromin and ethinyl estradiol7 mg in 1 POUCHPATCH72
70771-1777-3norelgestromin and ethinyl estradiol3 in 1 CARTONPATCH32

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-177770771-1777-1, 70771-1777-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
NORELGESTROMINR0TAY3X631ACTIB
ETHINYL ESTRADIOL423D2T571UACTIB
CROSPOVIDONE2S7830E561IACT
LAURYL LACTATEG5SU0BFK7OIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214594-001ETHINYL ESTRADIOL AND NORELGESTROMINETHINYL ESTRADIOL; NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A214594-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-1484e616aacf4f…
2026-08-18 06:07:402026-07A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-148072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-149b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214594-001ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2023-09-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A214594-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A214594-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214594-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214594-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214594-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214594-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214594-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214594-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214594-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214594-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214594-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214594-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214594-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214594-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214594-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214594-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214594-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214594-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214594-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214594-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214594-001AB19b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214594-001AB1a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
norelgestromin and ethinyl estradiolNORELGESTROMIN AND ETHINYL ESTRADIOLZydus Lifesciences Limited7c2cc8ab-db6d-4a1c-ae74-e0ef27e2f3a92026-04-16Exact identifier
ndc (package): 70771-1777-1
ndc (package): 70771-1777-3
ndc (product): 70771-1777
ndc11 (package): 70771177701
ndc11 (package): 70771177703
spl id: 81ceed98-7fc6-416f-8787-08cbdd76a856
spl set id: 7c2cc8ab-db6d-4a1c-ae74-e0ef27e2f3a9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.