Prescription drug · ANDA
Vinblastine Sulfate NDC 63323-278
Vinblastine sulfate 1 mg/mL · Injection · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-278-10 | 63323027810 | 1 VIAL, MULTI-DOSE in 1 BOX (63323-278-10) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Jul 12, 2000 |
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)
- Vinblastine Sulfate
- Generic name (nonproprietary)
- vinblastine sulfate
- Active ingredients
- Vinblastine sulfate — 1 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089515
- Marketing start
- Listing expires
- Other FDA classes
- Vinca Alkaloids (Chemical structure)
- Identifiers
- Product ID 63323-278_a6f97b09-27c2-4686-b89b-76dc77f44f50SPL ID a6f97b09-27c2-4686-b89b-76dc77f44f50SPL set ID f073b58e-56d6-4c8d-a2ce-b37719402d77RxCUI 239178UNII N00W22YO2BUPC 0363323278106
- 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
N463323027810followed by a unit qualifier and the quantityPackage 63323-0278-10. 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)
INDICATIONS AND USAGE: Vinblastine Sulfate Injection is indicated in the palliative treatment of the following: I. Frequently Responsive Malignancies • Generalized Hodgkin’s disease (Stages III and IV, Ann Arbor modification of Rye staging system) • Lymphocytic lymphoma (nodular and diffuse, poorly and well differentiated) • Histiocytic lymphoma • Mycosis fungoides (advanced stages) • Advanced carcinoma of the testis • Kaposi’s sarcoma • Letterer-Siwe disease (histiocytosis X) II. Less Frequently Responsive Malignancies • Choriocarcinoma resistant to other chemotherapeutic agents • Carcinoma of the breast, unresponsive to appropriate endocrine surgery and hormonal therapy Current principles …
Excerpt only. Read the full label for complete information.
About NDC 63323-278
- What is NDC 63323-278?
- 63323-278 is the product NDC for Vinblastine Sulfate, Vinblastine sulfate 1 mg/mL injection, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vinblastine Sulfate.
- What is the active ingredient?
- Vinblastine sulfate.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vinblastine Sulfate?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.