NDC 50484-010

COLLAGENASE SANTYL

Collagenase Santyl

COLLAGENASE SANTYL is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by Smith & Nephew, Inc. The primary component is Collagenase Clostridium Histolyticum.

Product ID50484-010_155959d1-0367-4fb6-8877-29099d08801c
NDC50484-010
Product TypeHuman Prescription Drug
Proprietary NameCOLLAGENASE SANTYL
Generic NameCollagenase Santyl
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2006-10-18
Marketing CategoryBLA / BLA
Application NumberBLA101995
Labeler NameSMITH & NEPHEW, INC
Substance NameCOLLAGENASE CLOSTRIDIUM HISTOLYTICUM
Active Ingredient Strength250 [arb'U]/g
Pharm ClassesCollagenases [Chemical/Ingredient],Collagen-specific Enzyme [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50484-010-30

1 TUBE in 1 CARTON (50484-010-30) > 30 g in 1 TUBE
Marketing Start Date2006-10-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50484-010-30 [50484001030]

COLLAGENASE SANTYL OINTMENT
Marketing CategoryBLA
Application NumberBLA101995
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2006-10-18

NDC 50484-010-15 [50484001015]

COLLAGENASE SANTYL OINTMENT
Marketing CategoryBLA
Application NumberBLA101995
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-10-18
Marketing End Date2017-04-04

NDC 50484-010-90 [50484001090]

COLLAGENASE SANTYL OINTMENT
Marketing CategoryBLA
Application NumberBLA101995
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2014-03-10

Drug Details

Active Ingredients

IngredientStrength
COLLAGENASE CLOSTRIDIUM HISTOLYTICUM250 [arb'U]/g

OpenFDA Data

SPL SET ID:6b6fbfc6-98fa-46aa-88ef-ab00fbb08ffd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309509
  • UPC Code
  • 0350484010300
  • Pharmacological Class

    • Collagenases [Chemical/Ingredient]
    • Collagen-specific Enzyme [EPC]

    Medicade Reported Pricing

    50484001090 SANTYL OINTMENT

    Pricing Unit: GM | Drug Type:

    50484001030 SANTYL OINTMENT

    Pricing Unit: GM | Drug Type:

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