DEFITELIO
- Product NDC
- 68727-800
- 11-digit product format
- 687270800
- Labeler code
- 68727
- Product ID
- 68727-800_0269ad44-e351-4411-8866-d8d53e28fb74
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- defibrotide sodium
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Jazz Pharmaceuticals, Inc.
- Application
- NDA208114
- Marketing category
- NDA
- Marketing start
- 2016-03-30
- Substance
- DEFIBROTIDE SODIUM
- Active strength
- 80 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DEFITELIO
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEFIBROTIDE SODIUM | 80 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L7CHH2B2J0 |
| Rxcui | 1746527, 1746532 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68727-800-01 | DEFITELIO | 2.5 mL in 1 VIAL | INJECTION, SOLUTION | 2.5 | | 8 |
| 68727-800-02 | DEFITELIO | 25 mL in 1 CARTON | INJECTION, SOLUTION | 25 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68727-800 | DEFITELIO (DEFIBROTIDE SODIUM) INJECTION, SOLUTION [JAZZ PHARMACEUTICALS, INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20221217_2c3db989-d7ad-41ed-9ebf-698dcf6c24ec.zip |
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 |
|---|
| 68727-800-01 | 68727080001 | 2.5 mL in 1 VIAL (68727-800-01) | 2.5 ml | 2016-03-30 | 0000-00-00 | No | No | Current |
| 68727-800-02 | 68727080002 | 25 mL in 1 CARTON (68727-800-02) | 25 ml | 2016-03-30 | 0000-00-00 | No | No | Current |