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
IngredientStrength
COLLAGENASE CLOSTRIDIUM HISTOLYTICUM250 [arb'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9X7O8V25IT
Rxcui309509

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fec04153-5a73-4a89-81d8-454536caa49fProduct name120210119

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50484-010-30COLLAGENASE SANTYL30 g in 1 TUBEOINTMENT303
50484-010-30COLLAGENASE SANTYL1 in 1 CARTONOINTMENT13
50484-010-90COLLAGENASE SANTYL1 in 1 CARTONOINTMENT13
50484-010-90COLLAGENASE SANTYL90 g in 1 TUBEOINTMENT903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50484-010-30GM - Gram50484-010bc0f0ce4-60e0-4e62-b4e0-5e4c319a8afb12016-07-19
50484-010-90GM - Gram50484-01056be641a-f3d9-4379-8f98-f28747ef131712016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COLLAGENASE CLOSTRIDIUM HISTOLYTICUMACTIVE INGREDIENT9X7O8V25ITCOLLAGENASE SANTYL OINTMENT [SMITH & NEPHEW, INC]1
COLLAGENASE CLOSTRIDIUM HISTOLYTICUMACTIVE MOIETY9X7O8V25ITCOLLAGENASE SANTYL OINTMENT [SMITH & NEPHEW, INC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCOLLAGENASE SANTYL OINTMENT [SMITH & NEPHEW, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50484-010COLLAGENASE SANTYL OINTMENT [SMITH & NEPHEW, INC]3Current NDC, Legacy NDC, 4 package rows20190521_6b6fbfc6-98fa-46aa-88ef-ab00fbb08ffd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309509collagenase 250 UNT per GM Topical OintmentPSN6b6fbfc6-98fa-46aa-88ef-ab00fbb08ffd3
309509collagenase 0.25 UNT/MG Topical OintmentSCD6b6fbfc6-98fa-46aa-88ef-ab00fbb08ffd3
309509collagenase 250 UNT per GM Topical OintmentSY6b6fbfc6-98fa-46aa-88ef-ab00fbb08ffd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50484-010-30504840010301 TUBE in 1 CARTON (50484-010-30) / 30 g in 1 TUBE1 tube2006-10-180000-00-00NoNoCurrent
50484-010-90504840010901 TUBE in 1 CARTON (50484-010-90) / 90 g in 1 TUBE1 tube2014-03-100000-00-00NoNoCurrent