Home NDC 67457-215-01 Melphalan Hydrochloride
Product NDC 67457-215
Requested package NDC 67457-215-01
11-digit product format 674570215
Labeler code 67457
Product ID 67457-215_64081e17-f72f-4e4f-9a4d-7744dade88ca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Melphalan Hydrochloride
Dosage form KIT
Labeler Mylan Institutional LLC
Application ANDA090270
Marketing category ANDA
Marketing start 2013-01-10
Marketing end 0000-00-00
Active strength 0
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A090270-001 MELPHALAN HYDROCHLORIDE MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090270-001 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 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090270-001 MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-09 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-215 MELPHALAN HYDROCHLORIDE KIT [MYLAN INSTITUTIONAL LLC] 5 Legacy NDC 20241004_8ce14d77-cf4a-4dd8-974b-3bce95bbaad3.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67457-215-01 67457021501 1 KIT in 1 CARTON (67457-215-01) * 10 mL in 1 VIAL, GLASS (67457-213-50) * 10 mL in 1 VIAL, GLASS (67457-214-10) 1 kit 2013-01-10 0000-00-00 No No Current