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#

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UNII Substances#

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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 · 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#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
90f7ab24-7839-4408-9a74-07bb6a79eaccnorgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral TabletPSN104These 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
90f7ab24-7839-4408-9a74-07bb6a79eaccethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral TabletSCD104These 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
90f7ab24-7839-4408-9a74-07bb6a79eaccethinyl estradiol 25 MCG / norgestimate 250 MCG Oral TabletSY104These 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-e063-6394a90a9357ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral TabletSY15These 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
2385591b-70ee-0577-e063-6394a90a9357ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral TabletSCD15These 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
2385591b-70ee-0577-e063-6394a90a9357norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral TabletPSN15These 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 TabletPSN15These 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
4d888008-cc14-4291-b384-0d482f48eb08ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral TabletSY15These 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
4d888008-cc14-4291-b384-0d482f48eb08ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral TabletSCD15These 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-5de4-4149-9857-081a9b4eb280ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral TabletSY14These 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
bc402baa-5de4-4149-9857-081a9b4eb280norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral TabletPSN14These 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
bc402baa-5de4-4149-9857-081a9b4eb280ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral TabletSCD14These 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 TabletPSN10These 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
d9d2d0a1-b336-40ee-b4cc-b3d876ca91b9ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral TabletSCD10These 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
d9d2d0a1-b336-40ee-b4cc-b3d876ca91b9ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral TabletSY10These 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-5ab2f3f8d5cbethinyl estradiol 25 MCG / norgestimate 250 MCG Oral TabletSY9These 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
ddbeb312-af2b-4d22-ab7c-5ab2f3f8d5cbethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral TabletSCD9These 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
ddbeb312-af2b-4d22-ab7c-5ab2f3f8d5cbnorgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral TabletPSN9These 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-5d49f10e4eeaethinyl estradiol 25 MCG / norgestimate 250 MCG Oral TabletSY7These 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
8381db98-f9b2-e894-c07e-5d49f10e4eeanorgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral TabletPSN7These 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
8381db98-f9b2-e894-c07e-5d49f10e4eeaethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral TabletSCD7These 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-41794450ef16ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral TabletSY6These 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
bd51a08e-cd45-4315-9bca-41794450ef16norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral TabletPSN6These 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
bd51a08e-cd45-4315-9bca-41794450ef16ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral TabletSCD6These 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-a74a5c3262a3ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral TabletSY4These 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
afdd0fea-eadb-4c40-b5a6-a74a5c3262a3ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral TabletSCD4These 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
afdd0fea-eadb-4c40-b5a6-a74a5c3262a3norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral TabletPSN4These 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 TabletPSN4These 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
d38f31bb-faba-40a8-bc60-2f78f2875ef2ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral TabletSCD4These 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
d38f31bb-faba-40a8-bc60-2f78f2875ef2ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral TabletSY4These 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-28dd6ff66765ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral TabletSY4ORTHO TRI-CYCLEN ® Lo Tablets (norgestimate/ethinyl estradiol)20110203
1b76e752-158a-44f4-9abf-28dd6ff66765norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral TabletPSN4ORTHO TRI-CYCLEN ® Lo Tablets (norgestimate/ethinyl estradiol)20110203
1b76e752-158a-44f4-9abf-28dd6ff66765ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral TabletSCD4ORTHO TRI-CYCLEN ® Lo Tablets (norgestimate/ethinyl estradiol)20110203
a3ce752d-58df-363d-e053-2a95a90a5411norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral TabletPSN3Norgestimate 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
a3ce752d-58df-363d-e053-2a95a90a5411ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral TabletSCD3Norgestimate 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
a3ce752d-58df-363d-e053-2a95a90a5411ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral TabletSY3Norgestimate 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-a488-21d65e7340f5ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral TabletSCD3These 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
b0c91536-7874-412d-a488-21d65e7340f5norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral TabletPSN3These 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
b0c91536-7874-412d-a488-21d65e7340f5ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral TabletSY3These 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 TabletPSN3These 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
d19ff955-1778-43c7-a111-476d740dc9d9ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral TabletSY3These 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
d19ff955-1778-43c7-a111-476d740dc9d9ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral TabletSCD3These 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-0d942243c790ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral TabletSCD1These 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
5f3dedb9-a500-4e21-8ffa-0d942243c790ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral TabletSY1These 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
5f3dedb9-a500-4e21-8ffa-0d942243c790norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral TabletPSN1These 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