Hepzato Kit NDC 75833-601

NDC codes

FDA NDC Directory

Product NDC (as listed)75833-601Labeler and product segments. Claims need a package NDC.

Product NDC at billing width75833-0601Add 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
75833-601-01	75833060101	1 KIT in 1 BOX (75833-601-01) * 5 VIAL, SINGLE-USE in 1 BOX (75833-700-01) / 10 mL in 1 VIAL, SINGLE-USE * 2 BAG in 1 BOX (75833-444-01) / 250 mL in 1 BAG * 5 VIAL, SINGLE-USE in 1 BOX (75833-800-01) / 10 mL in 1 VIAL, SINGLE-USEMarketed from Dec 4, 2023
75833-601-02	75833060102	1 KIT in 1 BOX (75833-601-02) * 5 VIAL, SINGLE-USE in 1 BOX (75833-700-01) / 10 mL in 1 VIAL, SINGLE-USE * 2 BAG in 1 BOX (75833-444-01) / 250 mL in 1 BAG * 5 VIAL, SINGLE-USE in 1 BOX (75833-800-01) / 10 mL in 1 VIAL, SINGLE-USEMarketed from Dec 4, 2023
75833-601-07	75833060107	1 KIT in 1 BOX (75833-601-07) * 5 VIAL, SINGLE-USE in 1 BOX (75833-700-01) / 10 mL in 1 VIAL, SINGLE-USE * 2 BAG in 1 BOX (75833-444-01) / 250 mL in 1 BAG * 5 VIAL, SINGLE-USE in 1 BOX (75833-800-01) / 10 mL in 1 VIAL, SINGLE-USEMarketed from Dec 4, 2023 · Sample package
75833-601-08	75833060108	1 KIT in 1 BOX (75833-601-08) * 5 VIAL, SINGLE-USE in 1 BOX (75833-700-01) / 10 mL in 1 VIAL, SINGLE-USE * 2 BAG in 1 BOX (75833-444-01) / 250 mL in 1 BAG * 5 VIAL, SINGLE-USE in 1 BOX (75833-800-01) / 10 mL in 1 VIAL, SINGLE-USEMarketed from Dec 4, 2023 · Sample package

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): Hepzato Kit
Generic name (nonproprietary): melphalan hydrochloride injection, powder, lyophilized, for solution
Dosage form: Kit
Route: Intra-arterial
Labeler: Delcath Systems, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 201848
Marketing start: Dec 4, 2023
Listing expires: Dec 31, 2027
Identifiers: Product ID 75833-601_6351a7fd-3941-4ddb-9c77-fb9225140151SPL ID 6351a7fd-3941-4ddb-9c77-fb9225140151SPL set ID 4f83c8f7-4cc0-4219-88d5-7cfddce91198RxCUI 311487, 2671196UPC 0375833700015, 0375833800012

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.

NDC on a medical claim

N475833060101 followed by a unit qualifier and the quantity

Package 75833-0601-01. 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 Jun 9, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

HEPZATO for injection, as a component of the HEPZATO KIT, is indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. HEPZATO is an alkylating drug indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resect…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)