Home NDC 23155-355 Melphalan hydrochloride
Product NDC 23155-355
11-digit product format 231550355
Labeler code 23155
Product ID 23155-355_64df9058-d4f2-4301-b5e4-19e3aed9747c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Melphalan hydrochloride
Dosage form KIT
Labeler Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application ANDA206523
Marketing category ANDA
Marketing start 2025-03-28
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 A206523-001 MELPHALAN HYDROCHLORIDE MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2024-10-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206523-001 AP
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 A206523-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2024-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206523-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2024-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206523-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2024-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206523-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2024-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206523-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2024-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206523-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2024-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206523-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2024-10-29 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206523-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2024-10-29 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206523-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2024-10-29 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Melphalan hydrochloride
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311487 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 23155-355-41 Melphalan hydrochloride 1 in 1 CARTON KIT 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 23155-355 MELPHALAN HYDROCHLORIDE (MELPHALAN HYDROCHLORIDE) KIT [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] 9 Current NDC, 1 package rows 20250330_2c18beeb-7bd4-4591-94cb-9d7156c1b8e0.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 23155-355-41 23155035541 1 KIT in 1 CARTON (23155-355-41) * 10 mL in 1 VIAL (23155-353-31) * 10 mL in 1 VIAL (23155-354-31) 1 kit 2025-03-28 No No Current