Home NDC 43598-392 Melphalan Hydrochloride
Product NDC 43598-392
11-digit product format 435980392
Labeler code 43598
Product ID 43598-392_7f4cc8ff-4b1c-86d8-ea19-0bab41202737
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Melphalan Hydrochloride
Dosage form KIT
Route INTRAVENOUS
Labeler Dr.Reddy's Laboratories Inc
Application ANDA203655
Marketing category ANDA
Marketing start 2017-12-18
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 A203655-001 MELPHALAN HYDROCHLORIDE MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203655-001 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.
Product history page 1 of 2 · 41 observed 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 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203655-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Melphalan Hydrochloride
Listing expiration 2026-12-31 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 43598-392-48 Melphalan Hydrochloride 1 in 1 CARTON KIT 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-392 MELPHALAN HYDROCHLORIDE KIT [DR.REDDY'S LABORATORIES INC] 8 Current NDC, Legacy NDC, 1 package rows 20210717_d4705154-3050-1a5c-950f-e24b51487401.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43598-392-48 43598039248 1 KIT in 1 CARTON (43598-392-48) * 10 mL in 1 VIAL, SINGLE-DOSE (43598-391-50) * 10 mL in 1 VIAL, SINGLE-USE (43598-393-35) 1 kit 2017-12-18 0000-00-00 No No Current