FDA.reportPublic FDA data

Balcoltra 28 Day Pack

RxCUI
1999026
RxNorm name
Balcoltra 28 Day Pack
Display name
Balcoltra 28 Day Pack
Full name
Balcoltra 28 Day Pack
Term type
SY
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#

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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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BalcoltraLEVONORGESTREL AND ETHINYL ESTRADIOLAvion Pharmaceuticals752ab698-4b48-4614-8016-d1d33ee7c0072025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1999026

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 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 [Balcoltra 28 Day] [BPCK] · Balcoltra 28 Day Pack [PSN] · Balcoltra 28 Day Pack [SY]36These 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