Prescription drug · ANDA
Vinorelbine NDC 45963-607
Vinorelbine tartrate 10 mg/mL · Injection, Solution · Intravenous · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45963-607-55 | 45963060755 | 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-55) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 1, 2015 | |
| 45963-607-56 | 45963060756 | 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-56) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 1, 2015 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Vinorelbine
- Generic name (nonproprietary)
- vinorelbine
- Active ingredients
- Vinorelbine tartrate — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078011
- Marketing start
- Listing expires
- Other FDA classes
- Vinca Alkaloids (Chemical structure)
- Identifiers
- Product ID 45963-607_1a467892-817b-4ff8-a58e-b69e0c3462ccSPL ID 1a467892-817b-4ff8-a58e-b69e0c3462ccSPL set ID dd3dcc9a-e40c-4677-9ee6-f318e7c7d835RxCUI 1729418, 1729422UNII 253GQW851QUPC 0345963607553
- Pharmacologic class
- Vinca Alkaloid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N445963060755followed by a unit qualifier and the quantityPackage 45963-0607-55. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Vinorelbine injection is indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) As a single agent for the treatment of patients with metastatic NSCLC Vinorelbine injection is a vinca alkaloid indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) ( 1 ) As a single agent for first-line treatment of patients with metastatic NSCLC ( 1 )
Excerpt only. Read the full label for complete information.