Home NDC 50484-810 REGRANEX
Product NDC 50484-810
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50484-810-15 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50484-810-15 f5e01cc5f278…a2eaf40c39c3…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BECAPLERMIN ACTIVE INGREDIENT 1B56C968OA REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] 1 BECAPLERMIN ACTIVE MOIETY 1B56C968OA REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] 1 ACETIC ACID INACTIVE INGREDIENT Q40Q9N063P REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] 1 LYSINE HYDROCHLORIDE INACTIVE INGREDIENT JNJ23Q2COM REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] 1 METACRESOL INACTIVE INGREDIENT GGO4Y809LO REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] 1 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50484-810 REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] 7 Legacy NDC 20231212_fd2c7d21-7b07-4ab3-8983-816ab3223771.zip
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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103691 Regranex becaplermin 351(a) Rx 2026-08-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50484-810-15 50484081015 1 TUBE in 1 CARTON (50484-810-15) > 15 g in 1 TUBE 1 tube 2014-08-01 0000-00-00 No No Current