FDA.reportPublic FDA data

{28 (ethinyl estradiol 0.005 MG / norethindrone acetate 1 MG Oral Tablet) } Pack

RxCUI
1251336
RxNorm name
{28 (ethinyl estradiol 0.005 MG / norethindrone acetate 1 MG Oral Tablet) } Pack
Display name
{28 (ethinyl estradiol 0.005 MG / norethindrone acetate 1 MG Oral Tablet) } Pack
Full name
{28 (ethinyl estradiol 0.005 MG / norethindrone acetate 1 MG Oral Tablet) } Pack
Term type
GPCK
Status
DailyMed mapping
Updated
2026-06-04 23:39:22

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 · 2 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: 1251336
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNivagen Pharmaceuticals, Inc.2c2a37e1-adaf-4947-abb1-736bfa58bf982023-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1251336

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
cf549b5a-2707-4020-9f94-dab1260e1664{28 (ethinyl estradiol 0.005 MG / norethindrone acetate 1 MG Oral Tablet) } PackGPCK6These 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-dab1260e1664Eth estra-Noreth Ac 0.005-1 MG (28) Oral Tablet 28 Day PackPSN6These 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-abb1-736bfa58bf98{28 (ethinyl estradiol 0.005 MG / norethindrone acetate 1 MG Oral Tablet) } PackGPCK5These 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-abb1-736bfa58bf98Eth estra-Noreth Ac 0.005-1 MG (28) Oral Tablet 28 Day PackPSN5These 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
434511bb-ebf9-4e25-9ef8-90e4c6786361Eth estra-Noreth Ac 0.005-1 MG (28) Oral Tablet 28 Day PackPSN1femhrt ® (norethindrone acetate/ethinyl estradiol tablets)20081002
434511bb-ebf9-4e25-9ef8-90e4c6786361{28 (ethinyl estradiol 0.005 MG / norethindrone acetate 1 MG Oral Tablet) } PackGPCK1femhrt ® (norethindrone acetate/ethinyl estradiol tablets)20081002