What is NDC 0517-4300?

0517-4300 is the product NDC for Paclitaxel Protein Bound Particles Albumin Bound, Paclitaxel 100 mg/20mL injection, powder, lyophilized, for suspension, listed with the FDA by American Regent, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Paclitaxel Protein Bound Particles Albumin Bound (Paclitaxel).

American Regent, Inc., NDC labeler code 0517. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Paclitaxel Protein Bound Particles Albumin Bound?

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.

NDC 0517-4300

NDC codes

FDA NDC Directory

Product NDC (as listed)0517-4300Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00517-4300Add 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
0517-4300-01	00517430001	1 VIAL in 1 CARTON (0517-4300-01) / 20 mL in 1 VIALMarketed from May 2, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Paclitaxel Protein Bound Particles Albumin Bound
Generic name (nonproprietary): paclitaxel
Active ingredients: Paclitaxel — 100 mg/20mL
Dosage form: Injection, Powder, Lyophilized, For suspension
Route: Intravenous
Labeler: American Regent, Inc.NDC labeler code 0517
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 211875
Marketing start: May 2, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Microtubule Inhibition (Physiologic effect)
Identifiers: Product ID 0517-4300_5db1c7ab-35c2-4764-b1ae-33f44560883bSPL ID 5db1c7ab-35c2-4764-b1ae-33f44560883bSPL set ID f06d1bb3-83f1-4d84-8004-4c6681ad8a5aRxCUI 583214UNII P88XT4IS4D
Pharmacologic class: Microtubule Inhibitor

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

N400517430001 followed by a unit qualifier and the quantity

Package 00517-4300-01. 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 May 1, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ( 1.1 ) Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ( 1.2 ) Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. ( 1.3 ) 1.1 Met…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0517-4300

What is NDC 0517-4300?: 0517-4300 is the product NDC for Paclitaxel Protein Bound Particles Albumin Bound, Paclitaxel 100 mg/20mL injection, powder, lyophilized, for suspension, listed with the FDA by American Regent, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Paclitaxel Protein Bound Particles Albumin Bound (Paclitaxel).
What is the active ingredient?: Paclitaxel.
Who is the labeler?: American Regent, Inc., NDC labeler code 0517. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Paclitaxel Protein Bound Particles Albumin Bound?: 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.

Paclitaxel Protein Bound Particles Albumin Bound (Paclitaxel) NDC 0517-4300