FDA.reportPublic FDA data

REGRANEX

Product NDC
50484-810
Requested package NDC
50484-810-15
11-digit product format
504840810
Labeler code
50484
Product ID
50484-810_be6974e1-70b7-4664-9c8a-b043c2ad2604
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
becaplermin
Dosage form
GEL
Route
TOPICAL
Labeler
Smith & Nephew, Inc.
Application
BLA103691
Marketing category
BLA
Marketing start
2011-11-01
Marketing end
0000-00-00
Substance
BECAPLERMIN
Active strength
100 ug/g
Pharmacologic classes
Human Platelet-derived Growth Factor [EPC],Platelet-Derived Growth Factor [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50484-81050484-810-15DDiscontinued by firm2026-07-31

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50484-810-15GM - Gram50484-810a022fb94-ac46-42ce-a3c8-0330abcba08812015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BECAPLERMINACTIVE INGREDIENT1B56C968OAREGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.]1
BECAPLERMINACTIVE MOIETY1B56C968OAREGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PREGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.]1
LYSINE HYDROCHLORIDEINACTIVE INGREDIENTJNJ23Q2COMREGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.]1
METACRESOLINACTIVE INGREDIENTGGO4Y809LOREGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TREGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHREGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.]1
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BREGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XREGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RREGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50484-810REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.]7Legacy NDC20231212_fd2c7d21-7b07-4ab3-8983-816ab3223771.zip

Purple Book Biologic Products#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50484-810-15504840810151 TUBE in 1 CARTON (50484-810-15) > 15 g in 1 TUBE1 tube2014-08-010000-00-00NoNoCurrent