FDA.reportPublic FDA data

ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet

RxCUI
749156
RxNorm name
ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet
Display name
ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet
Full name
ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:08

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 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLPD-Rx Pharmaceuticals, Inc.2385591b-70ee-0577-e063-6394a90a93572026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 749156
TRI-LO-MARZIANORGESTIMATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.bc402baa-5de4-4149-9857-081a9b4eb2802025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 749156
Tri-Lo- EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepack90f7ab24-7839-4408-9a74-07bb6a79eacc2024-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 749156
TRI-LO-MARZIANORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions4d888008-cc14-4291-b384-0d482f48eb082024-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 749156
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3ce752d-58df-363d-e053-2a95a90a54112024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 749156
Tri-Lo- EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLXiromed, LLC.8381db98-f9b2-e894-c07e-5d49f10e4eea2023-12-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 749156
Tri-VyLibra LoNORGESTIMATE AND ETHINYL ESTRADIOLAfaxys Pharma, LLCbd51a08e-cd45-4315-9bca-41794450ef162023-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 749156
Tri-Lo-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LPd38f31bb-faba-40a8-bc60-2f78f2875ef22023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 749156
Tri-Lo-MiliNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP5f3dedb9-a500-4e21-8ffa-0d942243c7902023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 749156
Tri-Lo-MiliNORGESTIMATE AND ETHINYL ESTRADIOLAurobindo Pharma Limitedd9d2d0a1-b336-40ee-b4cc-b3d876ca91b92022-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 749156
Tri-Lo-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.ddbeb312-af2b-4d22-ab7c-5ab2f3f8d5cb2021-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 749156
TRI-LO-MARZIANORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LPd19ff955-1778-43c7-a111-476d740dc9d92019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 749156

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 15 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
90f7ab24-7839-4408-9a74-07bb6a79eaccnorgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral Tablet [PSN] · ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet [SY]3104These highlights do not include all the information needed to use Tri-Lo-Estarylla safely and effectively. See full prescribing information for Tri-Lo-Estarylla. Tri-Lo-Estarylla ® (norgestimate and ethinyl estradiol tablets) for oral use Initial U.S. Approval: 198920240521
2385591b-70ee-0577-e063-6394a90a9357norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral Tablet [PSN] · ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet [SY]315These highlights do not include all the information needed to use TRI-LO-MARZIA safely and effectively. See full prescribing information for TRI-LO-MARZIA. TRI-LO-MARZIA™ (norgestimate and ethinyl estradiol tablets USP), for oral use Initial U.S. Approval: 198920250408
4d888008-cc14-4291-b384-0d482f48eb08norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral Tablet [PSN] · ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet [SY]315These highlights do not include all the information needed to use TRI-LO-MARZIA safely and effectively. See full prescribing information for TRI-LO-MARZIA. TRI-LO-MARZIA™ (norgestimate and ethinyl estradiol tablets USP), for oral use Initial U.S. Approval: 198920240310
bc402baa-5de4-4149-9857-081a9b4eb280norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral Tablet [PSN] · ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet [SY]314These highlights do not include all the information needed to use TRI-LO-MARZIA safely and effectively. See full prescribing information for TRI-LO-MARZIA. TRI-LO-MARZIA™ (norgestimate and ethinyl estradiol tablets USP), for oral use Initial U.S. Approval: 198920251209
d9d2d0a1-b336-40ee-b4cc-b3d876ca91b9norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral Tablet [PSN] · ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet [SY]310These highlights do not include all the information needed to use TRI-LO-MILI® safely and effectively. See full prescribing information for TRI-LO-MILI. TRI-LO-MILI (norgestimate and ethinyl estradiol) tablets for oral use Initial U.S. Approval: 198920220908
ddbeb312-af2b-4d22-ab7c-5ab2f3f8d5cbnorgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral Tablet [PSN] · ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet [SY]39These highlights do not include all the information needed to use TRI-LO-SPRINTEC safely and effectively. See full prescribing information for TRI-LO-SPRINTEC. TRI-LO-SPRINTEC ® (norgestimate/ethinyl estradiol) tablets for oral use Initial U.S. Approval: 198920211231
8381db98-f9b2-e894-c07e-5d49f10e4eeanorgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral Tablet [PSN] · ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet [SY]37These highlights do not include all the information needed to use Tri-Lo-Estarylla safely and effectively. See full prescribing information for Tri-Lo-Estarylla. Tri-Lo-Estarylla ® (norgestimate and ethinyl estradiol tablets) for oral use Initial U.S. Approval: 198920231221
bd51a08e-cd45-4315-9bca-41794450ef16norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral Tablet [PSN] · ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet [SY]36These highlights do not include all the information needed to use TRI-VYLIBRA ® LO safely and effectively. See full prescribing information for TRI-VYLIBRA ® LO. Tri-VyLibra ® Lo (norgestimate and ethinyl estradiol) tablets for oral use Initial U.S. Approval: 198920230504
afdd0fea-eadb-4c40-b5a6-a74a5c3262a3norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral Tablet [PSN] · ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet [SY]34These highlights do not include all the information needed to use TRI-VYLIBRA ® LO safely and effectively. See full prescribing information for TRI-VYLIBRA ® LO. Tri-VyLibra ® Lo (norgestimate and ethinyl estradiol) tablets for oral use Initial U.S. Approval: 198920230607
d38f31bb-faba-40a8-bc60-2f78f2875ef2norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral Tablet [PSN] · ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet [SY]34These highlights do not include all the information needed to use TRI-LO-SPRINTEC safely and effectively. See full prescribing information for TRI-LO-SPRINTEC. TRI-LO-SPRINTEC ® (norgestimate/ethinyl estradiol) tablets for oral use Initial U.S. Approval: 198920230201
1b76e752-158a-44f4-9abf-28dd6ff66765norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral Tablet [PSN] · ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet [SY]34ORTHO TRI-CYCLEN ® Lo Tablets (norgestimate/ethinyl estradiol)20110203
a3ce752d-58df-363d-e053-2a95a90a5411norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral Tablet [PSN] · ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet [SY]33Norgestimate 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
b0c91536-7874-412d-a488-21d65e7340f5norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral Tablet [PSN] · ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet [SY]33These 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, for oral use Initial U.S. Approval: 198920200118
d19ff955-1778-43c7-a111-476d740dc9d9norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral Tablet [PSN] · ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet [SY]33These highlights do not include all the information needed to use TRI-LO-MARZIA safely and effectively. See full prescribing information for TRI-LO-MARZIA TRI-LO-MARZIA™ (norgestimate and ethinyl estradiol tablets USP), for oral use Initial U.S. Approval: 198920191101
5f3dedb9-a500-4e21-8ffa-0d942243c790norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral Tablet [PSN] · ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet [SCD] · ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet [SY]31These highlights do not include all the information needed to use TRI-LO-MILI® safely and effectively. See full prescribing information for TRI-LO-MILI. TRI-LO-MILI (norgestimate and ethinyl estradiol) tablets for oral use Initial U.S. Approval: 198920230101