FDA.reportPublic FDA data

REGRANEX 0.01 % Topical Gel

RxCUI
213197
RxNorm name
REGRANEX 0.01 % Topical Gel
Display name
REGRANEX 0.01 % Topical Gel
Full name
REGRANEX 0.01 % Topical Gel
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:54

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103691Regranexbecaplermin351(a)Rx2026-08-01

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regranex Gel 0.01%BECAPLERMIN GEL 0.01%LRM Therapeutics, LLC377b3021-13d7-96d5-e063-6394a90a8ca32026-05-08Warnings, Adverse reactionsExact identifier
rxcui: 213197

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
377b3021-13d7-96d5-e063-6394a90a8ca3REGRANEX 0.01 % Topical Gel [PSN] · becaplermin 0.0001 MG/MG Topical Gel [Regranex] [SBD] · Regranex 0.0001 MG/MG Topical Gel [SY] · Regranex 0.01 % Topical Gel [SY] · Regranex 100 MCG per GM Topical Gel [SY]54These highlights do not include all the information needed to use REGRANEX ® gel safely and effectively. See full prescribing information for REGRANEX gel. REGRANEX (becaplermin) gel, for topical use Initial U.S. Approval: 199720260508