FDA.reportPublic FDA data

Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / ferrous bisglycinate 36.5 MG (7) Oral Tablet 28 Day Pack

RxCUI
2672923
RxNorm name
Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / ferrous bisglycinate 36.5 MG (7) Oral Tablet 28 Day Pack
Display name
Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / ferrous bisglycinate 36.5 MG (7) Oral Tablet 28 Day Pack
Full name
Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / ferrous bisglycinate 36.5 MG (7) Oral Tablet 28 Day Pack
Term type
PSN
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#

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levonorgestrel and ethinyl estradiolLEVONORGESTREL AND ETHINYL ESTRADIOLAcella Pharmaceuticals167b12a0-cdff-4081-a0a4-164482c239fa2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2672923
BalcoltraLEVONORGESTREL AND ETHINYL ESTRADIOLAvion Pharmaceuticals752ab698-4b48-4614-8016-d1d33ee7c0072025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2672923
MINZOYALEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS BISGLYCINATELupin Pharmaceuticals, Inc.d5ebd7fa-c388-4619-8dcb-e862e4ce52852025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2672923

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
752ab698-4b48-4614-8016-d1d33ee7c007{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (ferrous bisglycinate 36.5 MG Oral Tablet) } Pack [GPCK] · Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / ferrous bisglycinate 36.5 MG (7) Oral Tablet 28 Day Pack [PSN]26These highlights do not include all the information needed to use BALCOLTRA ® safely and effectively. See Full Prescribing Information for BALCOLTRA ® . BALCOLTRA ® (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) for oral administration Initial U.S. Approval: 199720251205
167b12a0-cdff-4081-a0a4-164482c239fa{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (ferrous bisglycinate 36.5 MG Oral Tablet) } Pack [GPCK] · Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / ferrous bisglycinate 36.5 MG (7) Oral Tablet 28 Day Pack [PSN]25These highlights do not include all the information needed to use LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND FERROUS BISGLYCINATE TABLETS safely and effectively. See Full Prescribing Information for LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND FERROUS BISGLYCINATE TABLETS. LEVONORGESTREL and ETHINYL ESTRADIOL tablets and FERROUS BISGLYCINATE tablets for oral administration Initial U.S. Approval: 199720251205
d5ebd7fa-c388-4619-8dcb-e862e4ce5285{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (ferrous bisglycinate 36.5 MG Oral Tablet) } Pack [GPCK] · Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / ferrous bisglycinate 36.5 MG (7) Oral Tablet 28 Day Pack [PSN]22These highlights do not include all the information needed to use MINZOYA safely and effectively. See full prescribing information for MINZOYA. MINZOYA (levonorgestrel and ethinyl estradiol tablets, and ferrous bisglycinate tablets), for oral use. Initial U.S. Approval: 1998.20250109