FDA.reportPublic FDA data

Eth estra-Levonorgest 0.03-0.15 MG (84) Oral Tablet / Inert 1 MG (7) Oral Tablet 3 Month Pack

RxCUI
751901
RxNorm name
Eth estra-Levonorgest 0.03-0.15 MG (84) Oral Tablet / Inert 1 MG (7) Oral Tablet 3 Month Pack
Display name
Eth estra-Levonorgest 0.03-0.15 MG (84) Oral Tablet / Inert 1 MG (7) Oral Tablet 3 Month Pack
Full name
Eth estra-Levonorgest 0.03-0.15 MG (84) Oral Tablet / Inert 1 MG (7) Oral Tablet 3 Month Pack
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:27

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levonorgestrel and ethinyl estradiolLEVONORGESTREL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA3d87d9a4-860a-4ea7-a993-0f4adf1789da2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 751901
SETLAKINLEVONORGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCb7b8ae08-3fb0-4c6c-af02-89f0f6f40ffb2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 751901
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.58e85e02-93e7-42ba-b8f5-a36290c684232025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 751901
JolessaLEVONORGESTREL / ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.f1076019-6f2c-4c90-9f3c-ab0c7cdd93152024-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 751901
INTROVALELEVONORGESTREL AND ETHINYL ESTRADIOL TABLETSXiromed LLC24abb5e1-5be4-87e7-404c-d8c2db25ffd02024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 751901
IcleviaLEVONORGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limited00657f4e-9df8-4f58-91a0-eff5a467f9882024-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 751901
IntrovaleLEVONORGESTREL AND ETHINYL ESTRADIOLXiromed, LLC.f5bc2427-3a18-e3e6-a058-210688e9c4462022-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 751901

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 9 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
58e85e02-93e7-42ba-b8f5-a36290c68423{84 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [GPCK] · Eth estra-Levonorgest 0.03-0.15 MG (84) Oral Tablet / Inert 1 MG (7) Oral Tablet 3 Month Pack [PSN]218These highlights do not include all the information needed to use levonorgestrel and ethinyl estradiol tablets safely and effectively. See full prescribing information for levonorgestrel and ethinyl estradiol tablets. LEVONORGESTREL and ETHINYL ESTRADIOL tablets for oral use Initial U.S. Approval: 198220251113
f1076019-6f2c-4c90-9f3c-ab0c7cdd9315{84 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [GPCK] · Eth estra-Levonorgest 0.03-0.15 MG (84) Oral Tablet / Inert 1 MG (7) Oral Tablet 3 Month Pack [PSN]218These highlights do not include all the information needed to use JOLESSA safely and effectively. See full prescribing information for JOLESSA . JOLESSA ® (levonorgestrel and ethinyl estradiol tablets) for oral use Initial U.S. Approval: 198220241024
b7b8ae08-3fb0-4c6c-af02-89f0f6f40ffb{84 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [GPCK] · Eth estra-Levonorgest 0.03-0.15 MG (84) Oral Tablet / Inert 1 MG (7) Oral Tablet 3 Month Pack [PSN]29These highlights do not include all the information needed to use SETLAKIN safely and effectively. See full prescribing information for SETLAKIN. SETLAKIN (levonorgestrel and ethinyl estradiol tablets) for oral use Initial U.S. Approval:198220251205
00657f4e-9df8-4f58-91a0-eff5a467f988{84 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [GPCK] · Eth estra-Levonorgest 0.03-0.15 MG (84) Oral Tablet / Inert 1 MG (7) Oral Tablet 3 Month Pack [PSN]29These highlights do not include all the information needed to use ICLEVIA safely and effectively. See full prescribing information for ICLEVIA. ICLEVIA (levonorgestrel and ethinyl estradiol tablets) for oral use Initial U.S. Approval: 198220240702
f5bc2427-3a18-e3e6-a058-210688e9c446{84 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [GPCK] · Eth estra-Levonorgest 0.03-0.15 MG (84) Oral Tablet / Inert 1 MG (7) Oral Tablet 3 Month Pack [PSN]27These highlights do not include all the information needed to use INTROVALE safely and effectively. See full prescribing information for INTROVALE. Introvale ® Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg for oral use Initial U.S. Approval: 198220220609
3d87d9a4-860a-4ea7-a993-0f4adf1789da{84 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [GPCK] · Eth estra-Levonorgest 0.03-0.15 MG (84) Oral Tablet / Inert 1 MG (7) Oral Tablet 3 Month Pack [PSN]26These highlights do not include all the information needed to use LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS. LEVONORGESTREL and ETHINYL ESTRADIOL tablets, for oral use Initial U.S. Approval: 198220260130
f1fa5297-01d6-4aad-a18e-0518ee8bb419{84 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [GPCK] · Eth estra-Levonorgest 0.03-0.15 MG (84) Oral Tablet / Inert 1 MG (7) Oral Tablet 3 Month Pack [PSN]23These highlights do not include all the information needed to use JOLESSA safely and effectively. See full prescribing information for JOLESSA . JOLESSA ® (levonorgestrel and ethinyl estradiol tablets) for oral use Initial U.S. Approval: 198220230607
24abb5e1-5be4-87e7-404c-d8c2db25ffd0{84 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [GPCK] · Eth estra-Levonorgest 0.03-0.15 MG (84) Oral Tablet / Inert 1 MG (7) Oral Tablet 3 Month Pack [PSN]21These highlights do not include all the information needed to use INTROVALE safely and effectively. See full prescribing information for INTROVALE . INTROVALE ® (levonorgestrel and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 198220241015
709031e4-4c20-4ea7-beff-6c459709a433{84 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [GPCK] · Eth estra-Levonorgest 0.03-0.15 MG (84) Oral Tablet / Inert 1 MG (7) Oral Tablet 3 Month Pack [PSN]2120110128