FDA.reportPublic FDA data

Regranex Gel 0.01%

Product NDC
85822-734
11-digit product format
858220734
Labeler code
85822
Product ID
85822-734_a76b93e5-1b94-4a52-8efc-52c09c797ed6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Becaplermin gel 0.01%
Dosage form
GEL
Route
TOPICAL
Labeler
LRM Therapeutics, LLC
Application
BLA103691
Marketing category
BLA
Marketing start
2025-06-13
Substance
BECAPLERMIN
Active strength
.1 mg/g
Pharmacologic classes
Human Platelet-derived Growth Factor [EPC], Platelet-Derived Growth Factor [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Regranex Gel 0.01%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BECAPLERMIN.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1B56C968OAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
213197Internal RxNorm lookup
308579Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
377b3021-13d7-96d5-e063-6394a90a8ca3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85822-734-15Regranex Gel 0.01%15 g in 1 TUBEGEL154

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
application number: BLA103691
ndc (product): 85822-734

Purple Book Biologic Products#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308579becaplermin 0.01 % Topical GelPSN377b3021-13d7-96d5-e063-6394a90a8ca34
213197REGRANEX 0.01 % Topical GelPSN377b3021-13d7-96d5-e063-6394a90a8ca34
213197becaplermin 0.0001 MG/MG Topical Gel [Regranex]SBD377b3021-13d7-96d5-e063-6394a90a8ca34
308579becaplermin 0.0001 MG/MG Topical GelSCD377b3021-13d7-96d5-e063-6394a90a8ca34
308579becaplermin 0.01 % Topical GelSY377b3021-13d7-96d5-e063-6394a90a8ca34
213197Regranex 0.0001 MG/MG Topical GelSY377b3021-13d7-96d5-e063-6394a90a8ca34
213197Regranex 0.01 % Topical GelSY377b3021-13d7-96d5-e063-6394a90a8ca34
213197Regranex 100 MCG per GM Topical GelSY377b3021-13d7-96d5-e063-6394a90a8ca34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85822-734-158582207341515 g in 1 TUBE (85822-734-15) 15 g2025-06-30NoNoCurrent