NDC codes

FDA NDC Directory
Product NDC (as listed)25021-204Labeler and product segments. Claims need a package NDC.
Product NDC at billing width25021-0204Add 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 NDC11-digit (billing)PackageCopy
25021-204-01250210204011 VIAL in 1 CARTON (25021-204-01) / 1 mL in 1 VIALMarketed from Sep 15, 2014
25021-204-05250210204051 VIAL in 1 CARTON (25021-204-05) / 5 mL in 1 VIALMarketed from Sep 15, 2014

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
Sagent PharmaceuticalsNDC labeler code 25021
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091106
Marketing start
Listing expires
Other FDA classes
Vinca Alkaloids (Chemical structure)
Identifiers
Product ID 25021-204_dfa03517-f452-450c-8eb6-d946c0350248SPL ID dfa03517-f452-450c-8eb6-d946c0350248SPL set ID 10a70995-e04d-4044-b1dc-c9aa27460397RxCUI 1729418, 1729422UNII 253GQW851Q
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

N425021020401 followed by a unit qualifier and the quantity

Package 25021-0204-01. 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.

Full label on DailyMed (opens in a new tab)

About NDC 25021-204

What is NDC 25021-204?
25021-204 is the product NDC for Vinorelbine, Vinorelbine tartrate 10 mg/mL injection, solution, listed with the FDA by Sagent Pharmaceuticals. 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?
Sagent Pharmaceuticals, NDC labeler code 25021. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
VinorelbineVinorelbine tartrate 10 mg/mLInjection, SolutionIntravenousActavis Pharma, Inc.45963-60745963-0607-5545963-0607-56

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