FDA.reportPublic FDA data

Estra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day Pack

RxCUI
1359127
RxNorm name
Estra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day Pack
Display name
Estra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day Pack
Full name
Estra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day Pack
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.

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Estradiol / Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEA-S Medication Solutionse166bdf6-eb60-49b8-9747-2a33c3e3461b2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359127
Estradiol and Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEIngenus Pharmaceuticals, LLC50c786d6-91bd-4eea-9455-ff2abc08372f2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359127
LOPREEZAESTRADIOL/NORETHINDRONE ACETATEAmneal Pharmaceuticals NY LLC966ac064-9eb7-4d15-b271-a7880ed1e79a2025-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359127
ABIGALE LOESTRADIOL AND NORETHINDRONE ACETATEXiromed LLCdf013d36-de10-0607-7e12-95ed43bf7ee92024-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359127
ESTRADIOL AND NORETHINDRONE ACETATEESTRADIOL AND NORETHINDRONE ACETATENaari Pte. Limitedf70185fe-9fcf-655f-e053-6394a90a20dc2024-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359127
MimveyESTRADIOL AND NORETHINDRONE ACETATETeva Pharmaceuticals USA, Inc.b1c5c06b-9ce2-4bf7-9693-e37608055a142024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359127
EtyqaESTRADIOL AND NORETHINDRONE ACETATEAurobindo Pharma Limitedafbc2a33-5eb2-4f01-91e9-07d8050da6ce2024-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359127
Estradiol / Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEBreckenridge Pharmaceutical, Inc.44125b2f-10ac-435c-bdb4-a29bf8450dbf2024-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359127
ActivellaESTRADIOL/NORETHINDRONE ACETATEAmneal Pharmaceuticals LLCd4b0c1dd-aae9-4ca2-958c-71dbe5d0fab02023-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359127
LopreezaESTRADIOL/NORETHINDRONE ACETATEAmneal Pharmaceuticals NY LLCbf0e39cb-95e7-4831-92d2-0b3f071aeaae2017-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359127

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
bf0e39cb-95e7-4831-92d2-0b3f071aeaaeEstra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day PackPSN19These 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-95e7-4831-92d2-0b3f071aeaae{28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } PackGPCK19These 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-71dbe5d0fab0{28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } PackGPCK18These 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-71dbe5d0fab0Estra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day PackPSN18These 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
b1c5c06b-9ce2-4bf7-9693-e37608055a14Estra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day PackPSN16These highlights do not include all the information needed to use MIMVEY TABLETS safely and effectively. See full prescribing information for MIMVEY TABLETS. MIMVEY ® (estradiol and norethindrone acetate) tablets, for oral use Initial U.S. Approval: 199820240531
b1c5c06b-9ce2-4bf7-9693-e37608055a14{28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } PackGPCK16These highlights do not include all the information needed to use MIMVEY TABLETS safely and effectively. See full prescribing information for MIMVEY TABLETS. MIMVEY ® (estradiol and norethindrone acetate) tablets, for oral use Initial U.S. Approval: 199820240531
966ac064-9eb7-4d15-b271-a7880ed1e79aEstra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day PackPSN10These 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-a7880ed1e79a{28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } PackGPCK10These 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-a29bf8450dbf{28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } PackGPCK10These 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-a29bf8450dbfEstra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day PackPSN10These 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-ff2abc08372f{28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } PackGPCK5These 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-ff2abc08372fEstra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day PackPSN5These 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
f70185fe-9fcf-655f-e053-6394a90a20dc{28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } PackGPCK5These 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: 199820240611
f70185fe-9fcf-655f-e053-6394a90a20dcEstra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day PackPSN5These 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: 199820240611
afbc2a33-5eb2-4f01-91e9-07d8050da6ce{28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } PackGPCK2These 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
afbc2a33-5eb2-4f01-91e9-07d8050da6ceEstra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day PackPSN2These 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-de10-0607-7e12-95ed43bf7ee9{28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } PackGPCK1These 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-de10-0607-7e12-95ed43bf7ee9Estra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day PackPSN1These 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
b85df980-7df1-4973-bee3-ae51274b588fEstra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day PackPSN1Estradiol/Norethindrone Acetate Tablets20120829
b85df980-7df1-4973-bee3-ae51274b588f{28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } PackGPCK1Estradiol/Norethindrone Acetate Tablets20120829