defitelio

Generic: defibrotide sodium

Labeler: jazz pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name defitelio
Generic Name defibrotide sodium
Labeler jazz pharmaceuticals, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

defibrotide sodium 80 mg/mL

Manufacturer
Jazz Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68727-800
Product ID 68727-800_0269ad44-e351-4411-8866-d8d53e28fb74
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208114
Listing Expiration 2026-12-31
Marketing Start 2016-03-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68727800
Hyphenated Format 68727-800

Supplemental Identifiers

RxCUI
1746527 1746532
UNII
L7CHH2B2J0

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 defitelio (source: ndc)
Generic Name defibrotide sodium (source: ndc)
Application Number NDA208114 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 80 mg/mL
source: ndc
Packaging
  • 2.5 mL in 1 VIAL (68727-800-01)
  • 25 mL in 1 CARTON (68727-800-02)
source: ndc

Packages (2)

68727-800-01 2.5 mL in 1 VIAL (68727-800-01) 68727-800-02 25 mL in 1 CARTON (68727-800-02)

Ingredients (1)

defibrotide sodium (80 mg/mL)

Linked Drug Pages (1)

DEFITELIO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "0269ad44-e351-4411-8866-d8d53e28fb74", "openfda": {"unii": ["L7CHH2B2J0"], "rxcui": ["1746527", "1746532"], "spl_set_id": ["2c3db989-d7ad-41ed-9ebf-698dcf6c24ec"], "manufacturer_name": ["Jazz Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2.5 mL in 1 VIAL (68727-800-01)", "package_ndc": "68727-800-01", "marketing_start_date": "20160330"}, {"sample": false, "description": "25 mL in 1 CARTON (68727-800-02)", "package_ndc": "68727-800-02", "marketing_start_date": "20160330"}], "brand_name": "DEFITELIO", "product_id": "68727-800_0269ad44-e351-4411-8866-d8d53e28fb74", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "68727-800", "generic_name": "defibrotide sodium", "labeler_name": "Jazz Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEFITELIO", "active_ingredients": [{"name": "DEFIBROTIDE SODIUM", "strength": "80 mg/mL"}], "application_number": "NDA208114", "marketing_category": "NDA", "marketing_start_date": "20160330", "listing_expiration_date": "20261231"}