NDC 64370-532
NAVELBINE
Vinorelbine Tartrate
NAVELBINE is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Pierre Fabre Pharmaceuticals, Inc.. The primary component is Vinorelbine Tartrate.
| Product ID | 64370-532_7e013efa-e6a9-cb83-e053-2991aa0a8980 |
| NDC | 64370-532 |
| Product Type | Human Prescription Drug |
| Proprietary Name | NAVELBINE |
| Generic Name | Vinorelbine Tartrate |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2005-11-15 |
| Marketing Category | NDA / NDA |
| Application Number | NDA020388 |
| Labeler Name | Pierre Fabre Pharmaceuticals, Inc. |
| Substance Name | VINORELBINE TARTRATE |
| Active Ingredient Strength | 10 mg/mL |
| Pharm Classes | Vinca Alkaloid [EPC],Vinca Alkaloids [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 64370-532-01
1 VIAL, SINGLE-USE in 1 CARTON (64370-532-01) > 1 mL in 1 VIAL, SINGLE-USE
| Marketing Start Date | 2005-11-15 |
| Marketing End Date | 2021-10-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 64370-532-02 [64370053202]
NAVELBINE INJECTION
| Marketing Category | NDA |
| Application Number | NDA020388 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2005-11-15 |
| Marketing End Date | 2021-10-31 |
NDC 64370-532-01 [64370053201]
NAVELBINE INJECTION
| Marketing Category | NDA |
| Application Number | NDA020388 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2005-11-15 |
| Marketing End Date | 2021-10-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| VINORELBINE TARTRATE | 10 mg/mL |
OpenFDA Data
| SPL SET ID: | 6d47c96a-7fdc-48ac-9250-41c5d3ecf8db |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
Pharmacological Class
- Vinca Alkaloid [EPC]
- Vinca Alkaloids [CS]
NDC Crossover Matching brand name "NAVELBINE" or generic name "Vinorelbine Tartrate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 64370-532 | NAVELBINE | Vinorelbine Tartrate |
| 0008-0045 | vinorelbine tartrate | vinorelbine tartrate |
Trademark Results [NAVELBINE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NAVELBINE 73632692 1452870 Live/Registered |
PIERRE FABRE MEDICAMENT 1986-11-28 |
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