Home NDC 75833-601 Hepzato Kit
Product NDC 75833-601
11-digit product format 758330601
Labeler code 75833
Product ID 75833-601_cc805aea-2daa-4855-8c1d-7233738b6e6f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name melphalan hydrochloride injection, powder, lyophilized, for solution
Dosage form KIT
Route INTRA-ARTERIAL
Labeler Delcath Systems, Inc.
Application NDA201848
Marketing category NDA
Marketing start 2023-12-04
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N201848-001 HEPZATO MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14
Orange Book patents# Current patent rows page 1 of 1 · 11 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N201848-001 10098997 2032-11-07 Drug product 2023-09-06 N201848-001 10369264 2032-11-07 Drug product 2023-09-06 N201848-001 10569004 2032-11-07 U-3680 2023-09-06 N201848-001 10569004 2032-11-07 U-3683 2023-09-06 N201848-001 11241522 2032-11-07 Drug product 2023-09-06 N201848-001 11633528 2032-11-07 U-3675 2023-09-06 N201848-001 11083831 2032-12-30 Drug product 2023-09-06 N201848-001 11833286 2032-12-30 Drug product 2023-12-27 N201848-001 10195334 2033-01-16 Drug product 2023-09-06 N201848-001 9314561 2034-02-07 Drug product 2023-09-06 N201848-001 9707331 2034-09-17 Drug product 2023-09-06
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N201848-001 NP 2026-08-14 N201848-001 ODE-438 2030-08-14
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N201848-001 HEPZATO EQ 50MG BASE/VIAL POWDER / INTRA-ARTERIAL RLD, RS 2023-08-14 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 6 · 217 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N201848-001 10098997 2032-11-07 Drug product 2023-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201848-001 10369264 2032-11-07 Drug product 2023-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201848-001 10569004 2032-11-07 U-3680 2023-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201848-001 10569004 2032-11-07 U-3683 2023-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201848-001 11241522 2032-11-07 Drug product 2023-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201848-001 11633528 2032-11-07 U-3675 2023-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201848-001 11083831 2032-12-30 Drug product 2023-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201848-001 11833286 2032-12-30 Drug product 2023-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201848-001 10195334 2033-01-16 Drug product 2023-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201848-001 9314561 2034-02-07 Drug product 2023-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201848-001 9707331 2034-09-17 Drug product 2023-09-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201848-001 10098997 2032-11-07 Drug product 2023-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201848-001 10369264 2032-11-07 Drug product 2023-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201848-001 10569004 2032-11-07 U-3680 2023-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201848-001 10569004 2032-11-07 U-3683 2023-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201848-001 11241522 2032-11-07 Drug product 2023-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201848-001 11633528 2032-11-07 U-3675 2023-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201848-001 11083831 2032-12-30 Drug product 2023-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201848-001 11833286 2032-12-30 Drug product 2023-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201848-001 10195334 2033-01-16 Drug product 2023-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201848-001 9314561 2034-02-07 Drug product 2023-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201848-001 9707331 2034-09-17 Drug product 2023-09-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201848-001 10098997 2032-11-07 Drug product 2023-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201848-001 10369264 2032-11-07 Drug product 2023-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201848-001 10569004 2032-11-07 U-3680 2023-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201848-001 10569004 2032-11-07 U-3683 2023-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201848-001 11241522 2032-11-07 Drug product 2023-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201848-001 11633528 2032-11-07 U-3675 2023-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201848-001 11083831 2032-12-30 Drug product 2023-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201848-001 11833286 2032-12-30 Drug product 2023-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201848-001 10195334 2033-01-16 Drug product 2023-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201848-001 9314561 2034-02-07 Drug product 2023-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201848-001 9707331 2034-09-17 Drug product 2023-09-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201848-001 10098997 2032-11-07 Drug product 2023-09-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201848-001 10369264 2032-11-07 Drug product 2023-09-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201848-001 10569004 2032-11-07 U-3680 2023-09-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201848-001 10569004 2032-11-07 U-3683 2023-09-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201848-001 11241522 2032-11-07 Drug product 2023-09-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201848-001 11633528 2032-11-07 U-3675 2023-09-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201848-001 11083831 2032-12-30 Drug product 2023-09-06 fd3edfee7708…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Hepzato Kit
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311487 Internal RxNorm lookup 2671196 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75833-444-01 Hepzato Kit 2 in 1 BOX INJECTION, SOLUTION 0.9 mg in 100mL 7 75833-444-01 Hepzato Kit 250 mL in 1 BAG INJECTION, SOLUTION 500 mL 0.9 mg in 100mL 7 75833-601-01 Hepzato Kit 1 in 1 BOX KIT 1 7 75833-601-02 Hepzato Kit 1 in 1 BOX KIT 1 7 75833-601-07 Hepzato Kit 1 in 1 BOX KIT 1 7 75833-601-08 Hepzato Kit 1 in 1 BOX KIT 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75833-601 HEPZATO KIT (MELPHALAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION) KIT [DELCATH SYSTEMS, INC.] 7 Current NDC, 6 package rows 20250522_4f83c8f7-4cc0-4219-88d5-7cfddce91198.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hepzato Kit MELPHALAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION Delcath Systems, Inc. 4f83c8f7-4cc0-4219-88d5-7cfddce91198 2026-06-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 201848 application number: NDA201848 ndc (product): 75833-601
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 75833-444-01 75833044401 2 in 1 BOX Historical 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-USE 1 kit 2023-12-04 No No Current 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-USE 1 kit 2023-12-04 No No Current 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-USE 1 kit 2023-12-04 Yes No Current 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-USE 1 kit 2023-12-04 Yes No Current