FDA.reportPublic FDA data

ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet

RxCUI
406396
RxNorm name
ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet
Display name
ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet
Full name
ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:01

RxNav Current And Historical NDCs#

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

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UNII Substances#

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

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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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA8b247e46-203e-4f5b-b5a7-cbd57341c7352026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 406396
Tri-EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutionsf7f7c073-48e0-4065-970b-8103d76b6eb02026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 406396
Norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.6e8bec6f-17ba-4b37-ae6c-07657815f2482025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 406396
Tri-LinyahNORGESTIMATE AND ETHINYL ESTRADIOLNorthstar Rx LLCb71a2b34-95bf-4430-83a0-1a4d1218ea3c2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 406396
Tri-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLPreferred Pharmaceuticals Inc.1f8b9aad-f31f-4cda-861d-c08a977fc9232025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 406396
Tri-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.843cbef6-cbfb-4a44-bb80-22930753e4c02025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 406396
Tri-EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepack6560d15f-6ce9-4f0e-9b59-043dec35ddd92024-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 406396
Norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLNaari Pte Limitedb936a6fb-27ed-44de-9199-8c656bcd366e2024-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 406396
Tri-VyLibraNORGESTIMATE AND ETHINYL ESTRADIOLAfaxys Pharma, LLCf59acc3e-21d9-4fa3-ad52-d77225739e1a2024-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 406396
norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3cfd79e-a344-1dfc-e053-2995a90a1ab72024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 406396
Tri-MiliNORGESTIMATE AND ETHINYL ESTRADIOLAurobindo Pharma Limited22cfceff-0429-466f-a015-33cfdc505d442024-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 406396
Tri-EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLXiromed, LLC.1ba8a8ab-eb09-0807-47d4-6b4055d10d912023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 406396
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions6ae97238-28cf-4bc9-a4ba-1e2bf4e3c6002023-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 406396
Tri-NymyoNORGESTIMATE AND ETHINYL ESTRADIOLMayne Pharma Inc.b13800f2-618f-468d-b8a5-2fc00595db612022-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 406396
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP4a159dcd-8af4-4e59-8f46-7b0fe5c228072022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 406396
Tri-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LPc1fc22e5-e02d-4dda-a9ac-c592e922c4672020-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 406396
Tri FemynorNORGESTIMATE AND ETHINYL ESTRADIOLAmneal Pharmaceuticals NY LLC46bbdf70-2b80-4359-a19b-d94ff99eac982016-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 406396

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 29 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
6560d15f-6ce9-4f0e-9b59-043dec35ddd9norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]2104These highlights do not include all the information needed to use Tri-Estarylla safely and effectively. See full prescribing information for Tri-Estarylla. Tri-Estarylla ® (norgestimate and ethinyl estradiol, USP) tablets, for oral use Initial U.S. Approval: 198920240521
8b247e46-203e-4f5b-b5a7-cbd57341c735norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]217These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 198920260206
843cbef6-cbfb-4a44-bb80-22930753e4c0norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]217These 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: 198920250312
22cfceff-0429-466f-a015-33cfdc505d44norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]213These highlights do not include all the information needed to use TRI-MILI safely and effectively. See full prescribing information for TRI-MILI. Tri-Mili ® (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 198920240102
b71a2b34-95bf-4430-83a0-1a4d1218ea3cnorgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]211These highlights do not include all the information needed to use Tri-Linyah safely and effectively. See full prescribing information for Tri-Linyah. Tri-Linyah (norgestimate/ethinyl estradiol) tablets, for oral use. Initial U.S. Approval: 198920251205
f59acc3e-21d9-4fa3-ad52-d77225739e1anorgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]210These highlights do not include all the information needed to use Tri-VyLibra safely and effectively. See full prescribing information for Tri-VyLibra. Tri-VyLibra ® (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 198920240202
1ba8a8ab-eb09-0807-47d4-6b4055d10d91norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]29These highlights do not include all the information needed to use Tri-Estarylla safely and effectively. See full prescribing information for Tri-Estarylla. Tri-Estarylla ® (norgestimate and ethinyl estradiol, USP) tablets, for oral use Initial U.S. Approval: 198920230801
6e8bec6f-17ba-4b37-ae6c-07657815f248norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]28These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP. NORGESTIMATE and ETHINYL ESTRADIOL tablets USP, for oral use Initial U.S. Approval: 198920251209
1f8b9aad-f31f-4cda-861d-c08a977fc923norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]28These 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: 198920251001
6ae97238-28cf-4bc9-a4ba-1e2bf4e3c600norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]28These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 198920230328
46bbdf70-2b80-4359-a19b-d94ff99eac98norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]26These highlights do not include all the information needed to use TRI FEMYNOR safely and effectively. See full prescribing information for TRI FEMYNOR. TRI FEMYNOR™ (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 198920160830
b936a6fb-27ed-44de-9199-8c656bcd366enorgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]25These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP. NORGESTIMATE and ETHINYL ESTRADIOL tablets USP, for oral use Initial U.S. Approval: 198920240423
4a159dcd-8af4-4e59-8f46-7b0fe5c22807norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]24These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 198920220401
f7f7c073-48e0-4065-970b-8103d76b6eb0norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]23These highlights do not include all the information needed to use Tri-Estarylla safely and effectively. See full prescribing information for Tri-Estarylla. Tri-Estarylla ® (norgestimate and ethinyl estradiol, USP) tablets, for oral use Initial U.S. Approval: 198920260127
a3cfd79e-a344-1dfc-e053-2995a90a1ab7norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]23Norgestimate and Ethinyl Estradiol Tablets, USP These highlights do not include all the information needed to use Norgestimate and Ethinyl Estradiol Tablets, USP safely and effectively. See full prescribing information for Norgestimate and Ethinyl Estradiol Tablets, USP. Initial U.S. Approval: 198920240110
02e5c9a1-6002-499e-abe2-8473a5854178norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]23These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 198920231004
63e95a36-47e5-4f62-b390-65937744f7f5norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]23These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 198920230607
8a4aa52f-fe7b-4814-9488-009fddfbfbb1norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]23These highlights do not include all the information needed to use Tri-VyLibra safely and effectively. See full prescribing information for Tri-VyLibra. Tri-VyLibra ® (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 198920230607
c1fc22e5-e02d-4dda-a9ac-c592e922c467norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]23Tri-Sprintec ® (norgestimate and ethinyl estradiol tablets USP)20200101
b13800f2-618f-468d-b8a5-2fc00595db61norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]22These 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
0d754d53-2a8b-40c8-9008-64390cd72dd0norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]22These highlights do not include all the information needed to use TRI FEMYNOR safely and effectively. See full prescribing information for TRI FEMYNOR. TRI FEMYNOR™ (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 198920200118
643b9e90-2bfc-411d-89cc-344add0e4205norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]22These highlights do not include all the information needed to use MonoNessa or TriNessa safely and effectively. See full prescribing information for MonoNessa and TriNessa. MonoNessa ® and TriNessa ® (norgestimate/ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 198920190412
c7de193c-d730-4f63-aa23-178b5f400967norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]22ORTHO TRI-CYCLEN ® TABLETS ORTHO-CYCLEN ® TABLETS (norgestimate/ethinyl estradiol)20120227
d9744d1c-032d-45a7-95aa-382831107a1dnorgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]21These 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 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]21TriNessa ® Tablets (norgestimate and ethinyl estradiol)20120523
faafb8ce-6955-4de4-8b93-ccc662123b5enorgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]21Tri-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 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]21TriNessa ® Tablets (norgestimate and ethinyl estradiol)20110913
7fd4976d-720c-40ee-8723-a703645d4ff0norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]21Tri-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 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet [PSN] · ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet [SCD]21Tri-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