FDA.reportPublic FDA data

ethinyl estradiol 2.5 MCG / norethindrone acetate 500 MCG Oral Tablet

RxCUI
1251323
RxNorm name
ethinyl estradiol 2.5 MCG / norethindrone acetate 500 MCG Oral Tablet
Display name
ethinyl estradiol 2.5 MCG / norethindrone acetate 500 MCG Oral Tablet
Full name
ethinyl estradiol 2.5 MCG / norethindrone acetate 500 MCG Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:04

RxNav Current And Historical NDCs#

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

No records found.

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USAcf549b5a-2707-4020-9f94-dab1260e16642026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1251323
FyavolvNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.772c86d7-10a4-48c5-8c19-f8aac68f5ab42026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1251323
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNivagen Pharmaceuticals, Inc.2c2a37e1-adaf-4947-abb1-736bfa58bf982023-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1251323

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
772c86d7-10a4-48c5-8c19-f8aac68f5ab4norethindrone acetate 0.5 MG / ethinyl estradiol 2.5 MCG Oral TabletPSN18These highlights do not include all the information needed to use FYAVOLV safely and effectively. See full prescribing information for FYAVOLV. Fyavolv TM (norethindrone acetate and ethinyl estradiol tablets USP), for oral use Initial U.S. Approval: 196820260106
772c86d7-10a4-48c5-8c19-f8aac68f5ab4ethinyl estradiol 0.0025 MG / norethindrone acetate 0.5 MG Oral TabletSCD18These highlights do not include all the information needed to use FYAVOLV safely and effectively. See full prescribing information for FYAVOLV. Fyavolv TM (norethindrone acetate and ethinyl estradiol tablets USP), for oral use Initial U.S. Approval: 196820260106
772c86d7-10a4-48c5-8c19-f8aac68f5ab4ethinyl estradiol 2.5 MCG / norethindrone acetate 500 MCG Oral TabletSY18These highlights do not include all the information needed to use FYAVOLV safely and effectively. See full prescribing information for FYAVOLV. Fyavolv TM (norethindrone acetate and ethinyl estradiol tablets USP), for oral use Initial U.S. Approval: 196820260106
cf549b5a-2707-4020-9f94-dab1260e1664ethinyl estradiol 0.0025 MG / norethindrone acetate 0.5 MG Oral TabletSCD6These highlights do not include all the information needed to use NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL safely and effectively. See full prescribing information for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL. NORETHINDRONE ACETATE and ETHINYL ESTRADIOL tablets, for oral use Initial U.S. Approval: 196820260129
cf549b5a-2707-4020-9f94-dab1260e1664ethinyl estradiol 2.5 MCG / norethindrone acetate 500 MCG Oral TabletSY6These highlights do not include all the information needed to use NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL safely and effectively. See full prescribing information for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL. NORETHINDRONE ACETATE and ETHINYL ESTRADIOL tablets, for oral use Initial U.S. Approval: 196820260129
cf549b5a-2707-4020-9f94-dab1260e1664norethindrone acetate 0.5 MG / ethinyl estradiol 2.5 MCG Oral TabletPSN6These highlights do not include all the information needed to use NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL safely and effectively. See full prescribing information for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL. NORETHINDRONE ACETATE and ETHINYL ESTRADIOL tablets, for oral use Initial U.S. Approval: 196820260129
2c2a37e1-adaf-4947-abb1-736bfa58bf98ethinyl estradiol 0.0025 MG / norethindrone acetate 0.5 MG Oral TabletSCD5These highlights do not include all the information needed to use NORETHINDRONE ACETATE and ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORETHINDRONE ACETATE and ETHINYL ESTRADIOL TABLETS. Norethindrone Acetate and Ethinyl Estradiol Tablets USP, for Oral Use Initial U.S. Approval: 196820231124
2c2a37e1-adaf-4947-abb1-736bfa58bf98norethindrone acetate 0.5 MG / ethinyl estradiol 2.5 MCG Oral TabletPSN5These highlights do not include all the information needed to use NORETHINDRONE ACETATE and ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORETHINDRONE ACETATE and ETHINYL ESTRADIOL TABLETS. Norethindrone Acetate and Ethinyl Estradiol Tablets USP, for Oral Use Initial U.S. Approval: 196820231124
2c2a37e1-adaf-4947-abb1-736bfa58bf98ethinyl estradiol 2.5 MCG / norethindrone acetate 500 MCG Oral TabletSY5These highlights do not include all the information needed to use NORETHINDRONE ACETATE and ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORETHINDRONE ACETATE and ETHINYL ESTRADIOL TABLETS. Norethindrone Acetate and Ethinyl Estradiol Tablets USP, for Oral Use Initial U.S. Approval: 196820231124