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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103691Regranexbecaplermin351(a)Rx2026-06-01

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