FDA.reportPublic FDA data

drospirenone 3 MG / ethinyl estradiol 0.03 MG / levomefolate calcium 0.451 MG Oral Tablet

RxCUI
1050492
RxNorm name
drospirenone 3 MG / ethinyl estradiol 0.03 MG / levomefolate calcium 0.451 MG Oral Tablet
Display name
drospirenone 3 MG / ethinyl estradiol 0.03 MG / levomefolate calcium 0.451 MG Oral Tablet
Full name
drospirenone 3 MG / ethinyl estradiol 0.03 MG / levomefolate calcium 0.451 MG Oral Tablet
Term type
SCD
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#

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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
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: 1050492
SafyralDROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUMBayer HealthCare Pharmaceuticals Inc.97563516-306a-4e17-9690-edbda49ecd832026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1050492
TydemyDROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUMLupin Pharmaceuticals, Inc.e4766132-4faa-4f76-89fe-75d4a6fd737b2025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1050492

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 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
97563516-306a-4e17-9690-edbda49ecd83drospirenone 3 MG / ethinyl estradiol 0.03 MG / levomefolate calcium 0.451 MG Oral Tablet [PSN] · drospirenone 3 MG / ethinyl estradiol 0.03 MG / 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
6928f186-190d-4c40-beab-81cf80cd45cbdrospirenone 3 MG / ethinyl estradiol 0.03 MG / levomefolate calcium 0.451 MG Oral Tablet [PSN] · drospirenone 3 MG / ethinyl estradiol 0.03 MG / 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
e4766132-4faa-4f76-89fe-75d4a6fd737bdrospirenone 3 MG / ethinyl estradiol 0.03 MG / levomefolate calcium 0.451 MG Oral Tablet [PSN] · drospirenone 3 MG / ethinyl estradiol 0.03 MG / 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