Home NDC 50484-010 COLLAGENASE SANTYL
Product NDC 50484-010
11-digit product format 504840010
Labeler code 50484
Product ID 50484-010_155959d1-0367-4fb6-8877-29099d08801c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name COLLAGENASE SANTYL
Dosage form OINTMENT
Route TOPICAL
Labeler SMITH & NEPHEW, INC
Application BLA101995
Marketing category BLA
Marketing start 2006-10-18
Substance COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
Active strength 250 [arb'U]/g
Pharmacologic classes Collagen-specific Enzyme [EPC], Collagenases [Chemical/Ingredient]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base COLLAGENASE SANTYL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength COLLAGENASE CLOSTRIDIUM HISTOLYTICUM 250 [arb'U]/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9X7O8V25IT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309509 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50484-010-30 COLLAGENASE SANTYL 30 g in 1 TUBE OINTMENT 30 3 50484-010-30 COLLAGENASE SANTYL 1 in 1 CARTON OINTMENT 1 3 50484-010-90 COLLAGENASE SANTYL 1 in 1 CARTON OINTMENT 1 3 50484-010-90 COLLAGENASE SANTYL 90 g in 1 TUBE OINTMENT 90 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50484-010 COLLAGENASE SANTYL OINTMENT [SMITH & NEPHEW, INC] 3 Current NDC, Legacy NDC, 4 package rows 20190521_6b6fbfc6-98fa-46aa-88ef-ab00fbb08ffd.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 101995 Santyl collagenase 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50484-010-30 50484001030 1 TUBE in 1 CARTON (50484-010-30) / 30 g in 1 TUBE 1 tube 2006-10-18 0000-00-00 No No Current 50484-010-90 50484001090 1 TUBE in 1 CARTON (50484-010-90) / 90 g in 1 TUBE 1 tube 2014-03-10 0000-00-00 No No Current