FDA.reportPublic FDA data

estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet

RxCUI
1359123
RxNorm name
estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet
Display name
estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet
Full name
estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:19

RxNav Current And Historical NDCs#

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

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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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Estradiol and Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEA-S Medication Solutions1521007a-546d-421e-99e1-e10d90c0b0902026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359123
Estradiol and Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEIngenus Pharmaceuticals, LLC50c786d6-91bd-4eea-9455-ff2abc08372f2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359123
LOPREEZAESTRADIOL/NORETHINDRONE ACETATEAmneal Pharmaceuticals NY LLC966ac064-9eb7-4d15-b271-a7880ed1e79a2025-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359123
ABIGALE LOESTRADIOL AND NORETHINDRONE ACETATEXiromed LLCdf013d36-de10-0607-7e12-95ed43bf7ee92024-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359123
EtyqaESTRADIOL AND NORETHINDRONE ACETATEAurobindo Pharma Limitedafbc2a33-5eb2-4f01-91e9-07d8050da6ce2024-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359123
Estradiol / Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEBreckenridge Pharmaceutical, Inc.44125b2f-10ac-435c-bdb4-a29bf8450dbf2024-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359123
ActivellaESTRADIOL/NORETHINDRONE ACETATEAmneal Pharmaceuticals LLCd4b0c1dd-aae9-4ca2-958c-71dbe5d0fab02023-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359123
LopreezaESTRADIOL/NORETHINDRONE ACETATEAmneal Pharmaceuticals NY LLCbf0e39cb-95e7-4831-92d2-0b3f071aeaae2017-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359123

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
bf0e39cb-95e7-4831-92d2-0b3f071aeaaeestradiol 0.5 MG / norethindrone acetate 0.1 MG Oral TabletPSN19These highlights do not include all the information needed to use LOPREEZA safely and effectively. See full prescribing information for LOPREEZA. LOPREEZA ® (estradiol/norethindrone acetate) tablets, for oral use Initial U.S. Approval: 199820171130
bf0e39cb-95e7-4831-92d2-0b3f071aeaaeestradiol 0.5 MG / norethindrone acetate 0.1 MG Oral TabletSCD19These highlights do not include all the information needed to use LOPREEZA safely and effectively. See full prescribing information for LOPREEZA. LOPREEZA ® (estradiol/norethindrone acetate) tablets, for oral use Initial U.S. Approval: 199820171130
d4b0c1dd-aae9-4ca2-958c-71dbe5d0fab0estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral TabletSCD18These highlights do not include all the information needed to use ACTIVELLA safely and effectively. See full prescribing information for ACTIVELLA. ACTIVELLA ® (estradiol/norethindrone acetate) tablets, for oral use Initial U.S. Approval: 199820231130
d4b0c1dd-aae9-4ca2-958c-71dbe5d0fab0estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral TabletPSN18These highlights do not include all the information needed to use ACTIVELLA safely and effectively. See full prescribing information for ACTIVELLA. ACTIVELLA ® (estradiol/norethindrone acetate) tablets, for oral use Initial U.S. Approval: 199820231130
966ac064-9eb7-4d15-b271-a7880ed1e79aestradiol 0.5 MG / norethindrone acetate 0.1 MG Oral TabletPSN10These highlights do not include all the information needed to use LOPREEZA safely and effectively. See full prescribing information for LOPREEZA. LOPREEZA ® (estradiol/norethindrone acetate) tablets, for oral use Initial U.S. Approval: 199820250116
966ac064-9eb7-4d15-b271-a7880ed1e79aestradiol 0.5 MG / norethindrone acetate 0.1 MG Oral TabletSCD10These highlights do not include all the information needed to use LOPREEZA safely and effectively. See full prescribing information for LOPREEZA. LOPREEZA ® (estradiol/norethindrone acetate) tablets, for oral use Initial U.S. Approval: 199820250116
44125b2f-10ac-435c-bdb4-a29bf8450dbfestradiol 0.5 MG / norethindrone acetate 0.1 MG Oral TabletSCD10These highlights do not include all the information needed to use ESTRADIOL/NORETHINDRONE ACETATE TABLETS safely and effectively. See full prescribing information for ESTRADIOL/NORETHINDRONE ACETATE TABLETS. ESTRADIOL / NORETHINDRONE ACETATE tablets, for oral use Initial U.S. Approval: 199820240221
44125b2f-10ac-435c-bdb4-a29bf8450dbfestradiol 0.5 MG / norethindrone acetate 0.1 MG Oral TabletPSN10These highlights do not include all the information needed to use ESTRADIOL/NORETHINDRONE ACETATE TABLETS safely and effectively. See full prescribing information for ESTRADIOL/NORETHINDRONE ACETATE TABLETS. ESTRADIOL / NORETHINDRONE ACETATE tablets, for oral use Initial U.S. Approval: 199820240221
50c786d6-91bd-4eea-9455-ff2abc08372festradiol 0.5 MG / norethindrone acetate 0.1 MG Oral TabletSCD5These highlights do not include all the information needed to use ESTRADIOL AND NORETHINDRONE ACETATE TABLETS safely and effectively. See full prescribing information for ESTRADIOL AND NORETHINDRONE ACETATE TABLETS. ESTRADIOL and NORETHINDRONE ACETATE tablets, for oral use Initial U.S. Approval: 199820260529
50c786d6-91bd-4eea-9455-ff2abc08372festradiol 0.5 MG / norethindrone acetate 0.1 MG Oral TabletPSN5These highlights do not include all the information needed to use ESTRADIOL AND NORETHINDRONE ACETATE TABLETS safely and effectively. See full prescribing information for ESTRADIOL AND NORETHINDRONE ACETATE TABLETS. ESTRADIOL and NORETHINDRONE ACETATE tablets, for oral use Initial U.S. Approval: 199820260529
afbc2a33-5eb2-4f01-91e9-07d8050da6ceestradiol 0.5 MG / norethindrone acetate 0.1 MG Oral TabletPSN2These highlights do not include all the information needed to use ETYQA safely and effectively. See full prescribing information for ETYQA. ETYQA (estradiol and norethindrone acetate) tablets, for oral use Initial U.S. Approval: 199820240301
afbc2a33-5eb2-4f01-91e9-07d8050da6ceestradiol 0.5 MG / norethindrone acetate 0.1 MG Oral TabletSCD2These highlights do not include all the information needed to use ETYQA safely and effectively. See full prescribing information for ETYQA. ETYQA (estradiol and norethindrone acetate) tablets, for oral use Initial U.S. Approval: 199820240301
df013d36-de10-0607-7e12-95ed43bf7ee9estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral TabletSCD1These highlights do not include all the information needed to use ABIGALE and ABIGALE LO safely and effectively. See full prescribing information for ABIGALE and ABIGALE LO . ABIGALE TM and ABIGALE TM LO (estradiol/norethindrone acetate) tablets, for oral use Initial U.S. Approval: 199820240917
df013d36-de10-0607-7e12-95ed43bf7ee9estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral TabletPSN1These highlights do not include all the information needed to use ABIGALE and ABIGALE LO safely and effectively. See full prescribing information for ABIGALE and ABIGALE LO . ABIGALE TM and ABIGALE TM LO (estradiol/norethindrone acetate) tablets, for oral use Initial U.S. Approval: 199820240917