What is NDC 45963-607?

45963-607 is the product NDC for Vinorelbine, Vinorelbine tartrate 10 mg/mL injection, solution, listed with the FDA by Actavis Pharma, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Actavis Pharma, Inc., NDC labeler code 45963. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Vinorelbine?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Vinorelbine NDC 45963-607 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)45963-607Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45963-0607Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
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.NDC labeler code 45963
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078011
Marketing start: Mar 1, 2015
Listing expires: Dec 31, 2026
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.

How CPT relates to drug billing

NDC on a medical claim

N445963060755 followed by a unit qualifier and the quantity

Package 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 May 31, 2022. 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.

Full label on DailyMed (opens in a new tab)

About NDC 45963-607

What is NDC 45963-607?: 45963-607 is the product NDC for Vinorelbine, Vinorelbine tartrate 10 mg/mL injection, solution, listed with the FDA by Actavis Pharma, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Vinorelbine.
What is the active ingredient?: Vinorelbine tartrate.
Who is the labeler?: Actavis Pharma, Inc., NDC labeler code 45963. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Vinorelbine?: 1 other product NDC are listed under this name. See all Vinorelbine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Vinorelbine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Vinorelbine	Vinorelbine tartrate 10 mg/mL	Injection, SolutionIntravenous	Sagent Pharmaceuticals	25021-204	25021-0204-0125021-0204-05