FDA.reportPublic FDA data

ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet

RxCUI
240128
RxNorm name
ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet
Display name
ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet
Full name
ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:24

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SprintecNORGESTIMATE AND ETHINYL ESTRADIOLPreferred Pharmaceuticals, Inc.90240210-0bca-4a55-99dc-19f2b40d8e3f2026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 240128
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepacke0b07fb6-8dbd-4e5d-b589-5191a1dc02ae2026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 240128
MONO-LINYAHNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions2ec8f18f-297c-405f-b191-a40767366bad2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 240128
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions35c6507c-555a-45ed-aaf6-8695831de71a2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 240128
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA8b247e46-203e-4f5b-b5a7-cbd57341c7352026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 240128
Tri-EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutionsf7f7c073-48e0-4065-970b-8103d76b6eb02026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 240128
Norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.6e8bec6f-17ba-4b37-ae6c-07657815f2482025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 240128
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.c25cd86c-2940-475a-9628-ee75b0294e8d2025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 240128
Tri-LinyahNORGESTIMATE AND ETHINYL ESTRADIOLNorthstar Rx LLCb71a2b34-95bf-4430-83a0-1a4d1218ea3c2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 240128
Tri-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLPreferred Pharmaceuticals Inc.1f8b9aad-f31f-4cda-861d-c08a977fc9232025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 240128
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLPD-Rx Pharmaceuticals, Inc.00dd9b78-dd90-414b-b241-7619aa9d1ed22025-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 240128
Tri-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.843cbef6-cbfb-4a44-bb80-22930753e4c02025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 240128
Mono-LinyahNORGESTIMATE AND ETHINYL ESTRADIOLNorthstar Rx LLC84a20017-344b-4684-a915-c85a55fcbbcb2025-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 240128
VyLibraNORGESTIMATE AND ETHINYL ESTRADIOLAfaxys Pharma, LLC13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc32025-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 240128
SprintecNORGESTIMATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.d9252820-131a-4870-8b11-945d1bfd56592024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 240128
MiliNORGESTIMATE AND ETHINYL ESTRADIOLAurobindo Pharma Limited76f14485-321d-4d4f-a3b0-aab195fd0dd12024-12-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 240128
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP7acde5ef-f457-4c47-897b-d048194c7d7e2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 240128
Tri-EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepack6560d15f-6ce9-4f0e-9b59-043dec35ddd92024-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 240128
Norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLNaari Pte Limitedb936a6fb-27ed-44de-9199-8c656bcd366e2024-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 240128
Norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLNaari Pte Limited03de435b-b8fb-4faa-a0ec-01e48b5aaae42024-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 240128

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 2 of 2 · 53 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
a522aff5-b02f-4e18-bf59-40bb0399e6fenorgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet [SY]32These highlights do not include all the information needed to use Nymyo safely and effectively. See full prescribing information for Nymyo. Nymyo (norgestimate/ethinyl estradiol tablets) for oral use. Initial U.S. Approval:198920221208
b13800f2-618f-468d-b8a5-2fc00595db61norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet [SY]32These highlights do not include all the information needed to use Tri-Nymyo safely and effectively. See full prescribing information forTri-Nymyo. Tri-Nymyo (norgestimate/ethinyl estradiol tablets) for oral use. Initial U.S. Approval: 198920221208
c7de193c-d730-4f63-aa23-178b5f400967norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet [SY]32ORTHO TRI-CYCLEN ® TABLETS ORTHO-CYCLEN ® TABLETS (norgestimate/ethinyl estradiol)20120227
7acde5ef-f457-4c47-897b-d048194c7d7enorgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet [SY]31These highlights do not include all the information needed to use Estarylla safely and effectively. See full prescribing information for Estarylla. Estarylla ® (NORGESTIMATE and ETHINYL ESTRADIOL tablets) for oral use Initial U.S. Approval: 198920241001
1cfc748b-2b54-6a6c-e063-6294a90a2930norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet [SY]31These highlights do not include all the information needed to use SPRINTEC safely and effectively. See full prescribing information for SPRINTEC. SPRINTEC ® (norgestimate/ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 198920240711
38d8c4ec-790b-4ff5-9d08-0ae230491e47norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet [SY]31These highlights do not include all the information needed to use MILI safely and effectively. See full prescribing information for MILI. MILI TM (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 198920190102
d9744d1c-032d-45a7-95aa-382831107a1dnorgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet [SY]31These highlights do not include all the information needed to use Tri-Sprintec safely and effectively. See full prescribing information for Tri-Sprintec. TRI-SPRINTEC ® (norgestimate/ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 198920160129
9599335c-4a8f-435d-b96c-27d5e5e34c39norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet [SY]31TriNessa ® Tablets (norgestimate and ethinyl estradiol)20120523
faafb8ce-6955-4de4-8b93-ccc662123b5enorgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet [SY]31Tri-Sprintec ® (norgestimate and ethinyl estradiol tablets - triphasic regimen) PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. Rx only20120419
69e66f08-be0b-4120-9a30-333b34ad3507norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet [SY]31TriNessa ® Tablets (norgestimate and ethinyl estradiol)20110913
7fd4976d-720c-40ee-8723-a703645d4ff0norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet [SY]31Tri-Sprintec ® (norgestimate and ethinyl estradiol tablets - triphasic regimen) PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. Rx only20110906
cbcb4427-7a99-467c-915f-a8b4c90e2832norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet [SY]31Tri-Sprintec ® (norgestimate and ethinyl estradiol tablets - triphasic regimen) PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. Rx only20110803
e2f5ed4f-dd97-4dda-83d1-f8edd8786c0enorgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet [SY]31Sprintec ® (norgestimate and ethinyl estradiol tablets) Rx only20110117