EVOMELA

Product NDC: 68152-109
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68152-109		D	Discontinued by firm		2026-08-11
excluded package	package	68152-109	68152-109-00	D	Discontinued by firm		2026-08-11

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68152-109-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68152-109-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68152-109-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68152-109-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68152-109-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68152-109-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68152-109-00	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68152-109-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68152-109-00	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68152-109-00	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68152-109-00	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68152-109-00	`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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207155-001	ODE-110	2023-03-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207155-001	ODE-110	2023-03-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207155-001	ODE-110	2023-03-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207155-001	ODE-110	2023-03-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207155-001	ODE-110	2023-03-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207155-001	ODE-110	2023-03-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207155-001	ODE-110	2023-03-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207155-001	ODE-110	2023-03-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207155-001	ODE-110	2023-03-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207155-001	ODE-110	2023-03-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207155-001	ODE-110	2023-03-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207155-001	ODE-110	2023-03-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207155-001	ODE-110	2023-03-10	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N207155-001	ODE-110	2023-03-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207155-001	ODE-110	2023-03-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207155-001	ODE-110	2023-03-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207155-001	ODE-110	2023-03-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207155-001	ODE-110	2023-03-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N207155-001	ODE-110	2023-03-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N207155-001	ODE-110	2023-03-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N207155-001	ODE-110	2023-03-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N207155-001	ODE-110	2023-03-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N207155-001	ODE-110	2023-03-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N207155-001	ODE-110	2023-03-10	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68152-109-00	2023-04-18	C162847	48780-1	f386c649-b1de-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use EVOMELA ® safely and effectively. See full prescribing information for EVOMELA. EVOMELA (melphalan) for injection, for intravenous use. Initial U.S. Approval: 1964
68152-109-00	2023-01-30	C162847	48780-1	f386c649-b1de-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use EVOMELA ® safely and effectively. See full prescribing information for EVOMELA. EVOMELA (melphalan) for injection, for intravenous use. Initial U.S. Approval: 1964

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68152-109-00	EA - Each	68152-109	98b13d80-8a9f-4227-bd97-6c90e421a110	1	2016-05-16

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1VXP4V453T	MELPHALAN HYDROCHLORIDE	3223-07-2	MELPHALAN HYDROCHLORIDE
Q41OR9510P	MELPHALAN	148-82-3	Melphalan

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EVOMELA	Acrotech Biopharma LLC \| Spectrum Pharmaceuticals, Inc.	2021-12-31	Human Prescription Drug Label	10