xiaflex

Generic: collagenase clostridium histolyticum

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name xiaflex
Generic Name collagenase clostridium histolyticum
Labeler endo usa, inc.
Dosage Form KIT
Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 66887-003
Product ID 66887-003_e232be6f-1c9b-493d-ba99-a8d29e92c0ff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125338
Listing Expiration 2027-12-31
Marketing Start 2010-02-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66887003
Hyphenated Format 66887-003

Supplemental Identifiers

RxCUI
898495 898499

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name xiaflex (source: ndc)
Generic Name collagenase clostridium histolyticum (source: ndc)
Application Number BLA125338 (source: ndc)

Resolved Composition

Strengths
  • 0.9 mg
  • 3 ml
  • 0.3 mg/ml
  • 0.9 %
source: label
Packaging
  • 1 KIT in 1 CARTON (66887-003-01) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 3 mL in 1 VIAL
  • 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
source: ndc

Packages (2)

66887-003-01 1 KIT in 1 CARTON (66887-003-01) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 3 mL in 1 VIAL 66887-003-02 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

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

XIAFLEX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "e232be6f-1c9b-493d-ba99-a8d29e92c0ff", "openfda": {"rxcui": ["898495", "898499"], "spl_set_id": ["805cecd0-fd1f-11dd-87af-0800200c9a66"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (66887-003-01)  *  1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL *  3 mL in 1 VIAL", "package_ndc": "66887-003-01", "marketing_start_date": "20100222"}, {"sample": false, "description": "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", "package_ndc": "66887-003-02", "marketing_start_date": "20100222"}], "brand_name": "XIAFLEX", "product_id": "66887-003_e232be6f-1c9b-493d-ba99-a8d29e92c0ff", "dosage_form": "KIT", "product_ndc": "66887-003", "generic_name": "collagenase clostridium histolyticum", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XIAFLEX", "application_number": "BLA125338", "marketing_category": "BLA", "marketing_start_date": "20100222", "listing_expiration_date": "20271231"}