FDA.reportPublic FDA data

levomefolate calcium 0.451 MG Oral Tablet

RxCUI
1013628
RxNorm name
levomefolate calcium 0.451 MG Oral Tablet
Display name
levomefolate calcium 0.451 MG Oral Tablet
Full name
levomefolate calcium 0.451 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:09

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calciumDROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUMSandoz Inc6928f186-190d-4c40-beab-81cf80cd45cb2026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1013628
SafyralDROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUMBayer HealthCare Pharmaceuticals Inc.97563516-306a-4e17-9690-edbda49ecd832026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1013628
BeyazDROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUMBayer HealthCare Pharmaceuticals Inc.8132454a-6135-4bac-b206-83a55eb8dbc62026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1013628
TydemyDROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUMLupin Pharmaceuticals, Inc.e4766132-4faa-4f76-89fe-75d4a6fd737b2025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1013628
drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calciumDROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUMLupin Pharmaceuticals, Inc.48f4301c-0426-43cd-af37-c4d8fc7aeb672025-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1013628
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate CalciumDROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUMSandoz Inc58cd12d3-39b1-4375-b7e0-09ba2378a52b2023-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1013628

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 7 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
97563516-306a-4e17-9690-edbda49ecd83levomefolate calcium 0.451 MG Oral Tablet [PSN] · levomefolate calcium 0.451 MG Oral Tablet [SCD]223These highlights do not include all the information needed to use SAFYRAL safely and effectively. See full prescribing information for SAFYRAL. SAFYRAL (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) for oral use Initial U.S. Approval: 201020260304
8132454a-6135-4bac-b206-83a55eb8dbc6levomefolate calcium 0.451 MG Oral Tablet [PSN] · levomefolate calcium 0.451 MG Oral Tablet [SCD]223These highlights do not include all the information needed to use BEYAZ safely and effectively. See full prescribing information for BEYAZ. BEYAZ (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets), for oral use Initial U.S. Approval: 201020260302
6928f186-190d-4c40-beab-81cf80cd45cblevomefolate calcium 0.451 MG Oral Tablet [PSN] · levomefolate calcium 0.451 MG Oral Tablet [SCD]217These highlights do not include all the information needed to use DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM TABLETS AND LEVOMEFOLATE CALCIUM TABLETS safely and effectively. See full prescribing information for safely and effectively. See full prescribing information for DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM . DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM TABLETS AND LEVOMEFOLATE CALCIUM TABLETS, for oral use Initial U.S. Approval: 201020260304
58cd12d3-39b1-4375-b7e0-09ba2378a52blevomefolate calcium 0.451 MG Oral Tablet [PSN] · levomefolate calcium 0.451 MG Oral Tablet [SCD]214These highlights do not include all the information needed to use DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM TABLETS AND LEVOMEFOLATE CALCIUM TABLETS safely and effectively. See full prescribing information for DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM. DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM TABLETS AND LEVOMEFOLATE CALCIUM TABLETS, for oral use. Initial U.S. Approval: 201020230519
48f4301c-0426-43cd-af37-c4d8fc7aeb67levomefolate calcium 0.451 MG Oral Tablet [PSN] · levomefolate calcium 0.451 MG Oral Tablet [SCD]29These highlights do not include all the information needed to use DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM TABLETS AND LEVOMEFOLATE CALCIUM TABLETS safely and effectively. See full prescribing information for DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM TABLETS AND LEVOMEFOLATE CALCIUM TABLETS. DROSPIRENONE, ETHINYL ESTRADIOL and LEVOMEFOLATE CALCIUM Tablets and LEVOMEFOLATE CALCIUM Tablets, for oral use Initial U.S. Approval: 201020251208
e4766132-4faa-4f76-89fe-75d4a6fd737blevomefolate calcium 0.451 MG Oral Tablet [PSN] · levomefolate calcium 0.451 MG Oral Tablet [SCD]28These highlights do not include all the information needed to use TYDEMY TM safely and effectively. See full prescribing information for TYDEMY TM . TYDEMY TM (drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets), for oral use Initial U.S. Approval: 201020251229
786fb677-58c9-44ca-9c67-595d6be0fe7flevomefolate calcium 0.451 MG Oral Tablet [PSN] · levomefolate calcium 0.451 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets safely and effectively. See full prescribing information for Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets. DROSPIRENONE, ETHINYL ESTRADIOL and LEVOMEFOLATE CALCIUM Tablets and LEVOMEFOLATE CALCIUM Tablets, for oral use Initial U.S. Approval: 201020201118