FDA.reportPublic FDA data

XIAFLEX

Product NDC
66887-003
11-digit product format
668870003
Labeler code
66887
Product ID
66887-003_4983f122-a210-4598-998f-03a6b719219f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
collagenase clostridium histolyticum
Dosage form
KIT
Labeler
Endo USA, Inc.
Application
BLA125338
Marketing category
BLA
Marketing start
2010-02-22
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
XIAFLEX
Listing expiration
2027-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui898495, 898499

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
fec04153-5a73-4a89-81d8-454536caa49fProduct name120210119
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66887-003-012023-09-22C16284748780-10191ceaa-6b54-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use XIAFLEX safely and effectively. See full prescribing information for XIAFLEX. XIAFLEX ® (collagenase clostridium histolyticum) for injection, for intralesional use Initial U.S. Approval: 2010
66887-003-012023-09-22C16284748780-10191ceaa-6b54-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use XIAFLEX safely and effectively. See full prescribing information for XIAFLEX. XIAFLEX ® (collagenase clostridium histolyticum) for injection, for intralesional use Initial U.S. Approval: 2010
66887-003-022023-09-22C16284748780-10191ceaa-6b54-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use XIAFLEX safely and effectively. See full prescribing information for XIAFLEX. XIAFLEX ® (collagenase clostridium histolyticum) for injection, for intralesional use Initial U.S. Approval: 2010
66887-003-022023-09-22C16284748780-10191ceaa-6b54-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use XIAFLEX safely and effectively. See full prescribing information for XIAFLEX. XIAFLEX ® (collagenase clostridium histolyticum) for injection, for intralesional use Initial U.S. Approval: 2010
66887-003-012023-07-28C16284748780-10191ceaa-6b54-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use XIAFLEX safely and effectively. See full prescribing information for XIAFLEX. XIAFLEX ® (collagenase clostridium histolyticum) for injection, for intralesional use Initial U.S. Approval: 2010
66887-003-012023-07-28C16284748780-10191ceaa-6b54-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use XIAFLEX safely and effectively. See full prescribing information for XIAFLEX. XIAFLEX ® (collagenase clostridium histolyticum) for injection, for intralesional use Initial U.S. Approval: 2010
66887-003-022023-07-28C16284748780-10191ceaa-6b54-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use XIAFLEX safely and effectively. See full prescribing information for XIAFLEX. XIAFLEX ® (collagenase clostridium histolyticum) for injection, for intralesional use Initial U.S. Approval: 2010
66887-003-022023-07-28C16284748780-10191ceaa-6b54-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use XIAFLEX safely and effectively. See full prescribing information for XIAFLEX. XIAFLEX ® (collagenase clostridium histolyticum) for injection, for intralesional use Initial U.S. Approval: 2010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66887-003-01XIAFLEX1 in 1 CARTONKIT146
66887-003-02XIAFLEX1 in 1 CARTONKIT146
66887-003-02XIAFLEX2 in 1 CARTONKIT246

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66887-003-01EA - Each66887-0034cf8a8e2-5051-4fe4-916f-47844c0267a712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COLLAGENASE CLOSTRIDIUM HISTOLYTICUMACTIVE INGREDIENT9X7O8V25ITXIAFLEX (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM) KIT [AUXILIUM PHARMACEUTICALS, INC.]13
COLLAGENASE CLOSTRIDIUM HISTOLYTICUMACTIVE MOIETY9X7O8V25ITXIAFLEX (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM) KIT [AUXILIUM PHARMACEUTICALS, INC.]13
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MXIAFLEX (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM) KIT [AUXILIUM PHARMACEUTICALS, INC.]13
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBXIAFLEX (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM) KIT [AUXILIUM PHARMACEUTICALS, INC.]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XXIAFLEX (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM) KIT [AUXILIUM PHARMACEUTICALS, INC.]13
SUCROSEINACTIVE INGREDIENTC151H8M554XIAFLEX (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM) KIT [AUXILIUM PHARMACEUTICALS, INC.]13
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VXIAFLEX (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM) KIT [AUXILIUM PHARMACEUTICALS, INC.]13
WATERINACTIVE INGREDIENT059QF0KO0RXIAFLEX (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM) KIT [AUXILIUM PHARMACEUTICALS, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66887-003XIAFLEX (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM) KIT [ENDO USA, INC.]43Current NDC, Legacy NDC, 3 package rows20240522_805cecd0-fd1f-11dd-87af-0800200c9a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898495collagenase Clostridium histolyticum 0.9 MG InjectionPSN805cecd0-fd1f-11dd-87af-0800200c9a6646
898499XIAFLEX 0.9 MG InjectionPSN805cecd0-fd1f-11dd-87af-0800200c9a6646
898499collagenase Clostridium histolyticum 0.9 MG Injection [Xiaflex]SBD805cecd0-fd1f-11dd-87af-0800200c9a6646
898495collagenase Clostridium histolyticum 0.9 MG InjectionSCD805cecd0-fd1f-11dd-87af-0800200c9a6646
898495collagenase Clostridium histolyticum 0.9 MG InjectionSY805cecd0-fd1f-11dd-87af-0800200c9a6646
898499Xiaflex 0.9 MG InjectionSY805cecd0-fd1f-11dd-87af-0800200c9a6646

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66887-003-01668870003011 KIT in 1 CARTON (66887-003-01) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 3 mL in 1 VIAL1 kit2010-02-220000-00-00NoNoCurrent
66887-003-02668870003022 CARTON in 1 CARTON (66887-003-02) / 1 KIT in 1 CARTON * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 3 mL in 1 VIAL2 carton2010-02-220000-00-00NoNoCurrent