Home NDC 66887-003 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 898495 Internal RxNorm lookup 898499 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 66887-003-01 2023-09-22 These 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 66887-003-01 2023-09-22 These 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 66887-003-02 2023-09-22 These 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 66887-003-02 2023-09-22 These 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 66887-003-01 2023-07-28 These 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 66887-003-01 2023-07-28 These 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 66887-003-02 2023-07-28 These 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 66887-003-02 2023-07-28 These 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 NDC Product Description Form Quantity Strength SPL version 66887-003-01 XIAFLEX 1 in 1 CARTON KIT 1 46 66887-003-02 XIAFLEX 1 in 1 CARTON KIT 1 46 66887-003-02 XIAFLEX 2 in 1 CARTON KIT 2 46
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded COLLAGENASE CLOSTRIDIUM HISTOLYTICUM ACTIVE INGREDIENT 9X7O8V25IT XIAFLEX (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM) KIT [AUXILIUM PHARMACEUTICALS, INC.] 13 COLLAGENASE CLOSTRIDIUM HISTOLYTICUM ACTIVE MOIETY 9X7O8V25IT XIAFLEX (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM) KIT [AUXILIUM PHARMACEUTICALS, INC.] 13 CALCIUM CHLORIDE INACTIVE INGREDIENT M4I0D6VV5M XIAFLEX (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM) KIT [AUXILIUM PHARMACEUTICALS, INC.] 13 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB XIAFLEX (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM) KIT [AUXILIUM PHARMACEUTICALS, INC.] 13 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X XIAFLEX (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM) KIT [AUXILIUM PHARMACEUTICALS, INC.] 13 SUCROSE INACTIVE INGREDIENT C151H8M554 XIAFLEX (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM) KIT [AUXILIUM PHARMACEUTICALS, INC.] 13 TROMETHAMINE INACTIVE INGREDIENT 023C2WHX2V XIAFLEX (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM) KIT [AUXILIUM PHARMACEUTICALS, INC.] 13 WATER INACTIVE INGREDIENT 059QF0KO0R XIAFLEX (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM) KIT [AUXILIUM PHARMACEUTICALS, INC.] 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66887-003 XIAFLEX (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM) KIT [ENDO USA, INC.] 43 Current NDC, Legacy NDC, 3 package rows 20240522_805cecd0-fd1f-11dd-87af-0800200c9a66.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join XIAFLEX COLLAGENASE CLOSTRIDIUM HISTOLYTICUM Endo USA, Inc. 805cecd0-fd1f-11dd-87af-0800200c9a66 2026-04-22 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125338 ndc (product): 66887-003
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125338 Xiaflex collagenase clostridium histolyticum 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 66887-003-01 66887000301 1 KIT in 1 CARTON (66887-003-01) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 3 mL in 1 VIAL 1 kit 2010-02-22 0000-00-00 No No Current 66887-003-02 66887000302 2 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 VIAL 2 carton 2010-02-22 0000-00-00 No No Current