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NDC 68727-0800-01 DEFITELIO 80 mg/mL Details
DEFITELIO 80 mg/mL
DEFITELIO is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Jazz Pharmaceuticals, Inc.. The primary component is DEFIBROTIDE SODIUM.
MedlinePlus Drug Summary
Defibrotide injection is used to treat adults and children with hepatic veno-occlusive disease (VOD; blocked blood vessels inside the liver, also known as sinusoidal obstruction syndrome), who have kidney or lung problems after receiving a hematopoietic stem-cell transplant (HSCT; procedure in which certain blood cells are removed from the body and then returned to the body). Defibrotide injection is in a class of medications called antithrombotic agents. It works by preventing the formation of blood clots.
Related Packages: 68727-0800-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Defibrotide Injection
Product Information
| NDC | 68727-0800 |
|---|---|
| Product ID | 68727-800_0173efe0-e4e2-41f6-b044-81f707120906 |
| Associated GPIs | 85650030102020 |
| GCN Sequence Number | 070243 |
| GCN Sequence Number Description | defibrotide sodium VIAL 80 MG/ML INTRAVEN |
| HIC3 | M9U |
| HIC3 Description | THROMBOLYTIC - NUCLEOTIDE TYPE |
| GCN | 33719 |
| HICL Sequence Number | 026300 |
| HICL Sequence Number Description | DEFIBROTIDE SODIUM |
| Brand/Generic | Brand |
| Proprietary Name | DEFITELIO |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | defibrotide sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 80 |
| Active Ingredient Units | mg/mL |
| Substance Name | DEFIBROTIDE SODIUM |
| Labeler Name | Jazz Pharmaceuticals, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208114 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68727-0800-01 (68727080001)
| NDC Package Code | 68727-800-01 |
|---|---|
| Billing NDC | 68727080001 |
| Package | 2.5 mL in 1 VIAL (68727-800-01) |
| Marketing Start Date | 2016-03-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |