Home NDC 68152-109-00 EVOMELA
Product NDC 68152-109
Requested package NDC 68152-109-00
11-digit product format 681520109
Labeler code 68152
Product ID 68152-109_dd7dd217-449f-49aa-b839-eee22d963459
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Melphalan
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Acrotech Biopharma LLC
Application NDA207155
Marketing category NDA
Marketing start 2016-03-31
Marketing end 0000-00-00
Substance MELPHALAN HYDROCHLORIDE
Active strength 50 mg/10mL
Pharmacologic classes Alkylating Activity [MoA],Alkylating Drug [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
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 N207155-001 EVOMELA MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207155-001 8410077 2029-03-13 Drug product 2016-04-05 N207155-001 9200088 2029-03-13 Drug product 2016-04-05 N207155-001 10864183 2030-05-28 Drug product 2020-12-15 N207155-001 11020363 2030-05-28 Drug product 2021-06-10 N207155-001 10940128 2030-06-14 U-3086 Drug product 2021-03-19 N207155-001 9493582 2033-02-27 Drug product 2017-03-14 N207155-001 10040872 2034-01-30 Drug product 2018-09-06
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 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N207155-001 EVOMELA EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2016-03-10 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 7 · 266 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 N207155-001 8410077 2029-03-13 Drug product 2016-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207155-001 9200088 2029-03-13 Drug product 2016-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207155-001 10864183 2030-05-28 Drug product 2020-12-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207155-001 11020363 2030-05-28 Drug product 2021-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207155-001 10940128 2030-06-14 U-3086 Drug product 2021-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207155-001 9493582 2033-02-27 Drug product 2017-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207155-001 10040872 2034-01-30 Drug product 2018-09-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207155-001 8410077 2029-03-13 Drug product 2016-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207155-001 9200088 2029-03-13 Drug product 2016-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207155-001 10864183 2030-05-28 Drug product 2020-12-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207155-001 11020363 2030-05-28 Drug product 2021-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207155-001 10940128 2030-06-14 U-3086 Drug product 2021-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207155-001 9493582 2033-02-27 Drug product 2017-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207155-001 10040872 2034-01-30 Drug product 2018-09-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207155-001 8410077 2029-03-13 Drug product 2016-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207155-001 9200088 2029-03-13 Drug product 2016-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207155-001 10864183 2030-05-28 Drug product 2020-12-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207155-001 11020363 2030-05-28 Drug product 2021-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207155-001 10940128 2030-06-14 U-3086 Drug product 2021-03-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207155-001 9493582 2033-02-27 Drug product 2017-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207155-001 10040872 2034-01-30 Drug product 2018-09-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207155-001 8410077 2029-03-13 Drug product 2016-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207155-001 9200088 2029-03-13 Drug product 2016-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207155-001 10864183 2030-05-28 Drug product 2020-12-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207155-001 11020363 2030-05-28 Drug product 2021-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207155-001 10940128 2030-06-14 U-3086 Drug product 2021-03-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207155-001 9493582 2033-02-27 Drug product 2017-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207155-001 10040872 2034-01-30 Drug product 2018-09-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207155-001 8410077 2029-03-13 Drug product 2016-04-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207155-001 9200088 2029-03-13 Drug product 2016-04-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207155-001 10864183 2030-05-28 Drug product 2020-12-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207155-001 11020363 2030-05-28 Drug product 2021-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207155-001 10940128 2030-06-14 U-3086 Drug product 2021-03-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207155-001 9493582 2033-02-27 Drug product 2017-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207155-001 10040872 2034-01-30 Drug product 2018-09-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207155-001 8410077 2029-03-13 Drug product 2016-04-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207155-001 9200088 2029-03-13 Drug product 2016-04-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207155-001 10864183 2030-05-28 Drug product 2020-12-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207155-001 11020363 2030-05-28 Drug product 2021-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207155-001 10940128 2030-06-14 U-3086 Drug product 2021-03-19 03ed91905a0d…
Observed Orange Book exclusivity history# FDA-Initiated Inactive NDC Indexing# 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 EVOMELA MELPHALAN Acrotech Biopharma Inc 69f55869-dc11-408e-8fc7-47634269a52c 2023-06-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 207155 application number: NDA207155
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68152-109-00 68152010900 1 VIAL in 1 CARTON (68152-109-00) > 20 mL in 1 VIAL 1 vial 2016-03-31 2022-03-31 No No Current