What is NDC 50633-210?

50633-210 is the product NDC for Voraxaze (glucarpidase), Glucarpidase 1000 [USP'U]/1 injection, powder, for solution, listed with the FDA by BTG International Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

BTG International Inc., NDC labeler code 50633. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Voraxaze?

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.

Voraxaze NDC 50633-210 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50633-210Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50633-0210Add 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
50633-210-11	5063302101150633021011	1 VIAL in 1 CARTON (50633-210-11) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIALMarketed from Apr 1, 2012

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): Voraxaze
Generic name (nonproprietary): glucarpidase
Active ingredients: Glucarpidase — 1000 [USP'U]/1
Dosage form: Injection, Powder, For solution
Route: Intravenous
Labeler: BTG International Inc.NDC labeler code 50633
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 125327
Marketing start: Apr 1, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Carboxypeptidases (Chemical structure)
Identifiers: Product ID 50633-210_27e39e9a-42e0-fb03-e063-6394a90aae3eSPL ID 27e39e9a-42e0-fb03-e063-6394a90aae3eSPL set ID acaef5a6-b740-40e3-8ffe-74a75c74745cRxCUI 1242131, 1242136UNII 2GFP9BJD79
Pharmacologic class: Carboxypeptidase

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

N450633021011 followed by a unit qualifier and the quantity

Package 50633-0210-11. 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 Nov 27, 2024.

Indications (excerpt from the label)

VORAXAZE is indicated to reduce toxic plasma methotrexate concentration (greater than 1 micromole per liter) in adult and pediatric patients with delayed methotrexate clearance (plasma methotrexate concentrations greater than 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered) due to impaired renal function. Limitations of Use: VORAXAZE is not recommended for use in patients who exhibit the expected clearance and expected plasma methotrexate concentration. Reducing plasma methotrexate concentration in these patients may result in subtherapeutic exposure to methotrexate [see Clinical Studies ( 14 )] . VORAXAZE is a carboxypeptidas…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50633-210

What is NDC 50633-210?: 50633-210 is the product NDC for Voraxaze (glucarpidase), Glucarpidase 1000 [USP'U]/1 injection, powder, for solution, listed with the FDA by BTG International Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Voraxaze (Glucarpidase).
What is the active ingredient?: Glucarpidase.
Who is the labeler?: BTG International Inc., NDC labeler code 50633. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Voraxaze?: 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.

Voraxaze (Glucarpidase) NDC 50633-210