Melphalan Hydrochloride

Product NDC: 84679-001
Requested package NDC: 84679-001-01
11-digit product format: 846790001
Labeler code: 84679
Product ID: 84679-001_47e47c3a-eecb-263c-e063-6394a90a8864
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: melphalan hydrochloride
Dosage form: KIT
Route: INTRAVENOUS
Labeler: Arthur Group LLC
Application: ANDA211463
Marketing category: ANDA
Marketing start: 2024-11-30
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A211463-001	MELPHALAN HYDROCHLORIDE	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP		2019-09-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A211463-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		2019-09-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211463-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-09-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211463-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211463-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211463-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211463-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211463-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211463-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211463-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211463-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211463-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211463-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211463-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211463-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211463-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211463-001	AP	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A211463-001	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A211463-001	AP	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211463-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211463-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211463-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211463-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211463-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211463-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211463-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211463-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211463-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211463-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211463-001	AP	1	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211463-001	AP	1	`a50c72e98297…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2254450e-4803-b947-e063-6394a90a4624	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f87e8f-8550-4326-8f00-643b28e8aa5f	Product name	8	20250617
d20f1fbb-d49e-414f-841c-a03ebbf763aa	Product name	1	20241009
095b9d9e-47ea-8623-0363-760d047199b8	Product name	2	20170607
f096f23d-a1a3-49d0-b114-cd8666319a02	Product name	1	20160422

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84679-001-01	Melphalan Hydrochloride	1 in 1 CARTON	KIT	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84679-001	MELPHALAN HYDROCHLORIDE KIT [ARTHUR GROUP LLC]	1	Current NDC, 1 package rows	20241130_2254450e-4803-b947-e063-6394a90a4624.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Melphalan Hydrochloride	MELPHALAN HYDROCHLORIDE	Arthur Group LLC	2254450e-4803-b947-e063-6394a90a4624	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211463 application number: ANDA211463 ndc (package): 84679-001-01 ndc (product): 84679-001 ndc11 (package): 84679000101
Melphalan Hydrochloride	MELPHALAN HYDROCHLORIDE	Qilu Pharmaceutical Co., Ltd.	91948ff9-6070-485b-b4b7-3cb477c1b24c	2024-07-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211463 application number: ANDA211463
Melphalan Hydrochloride	MELPHALAN HYDROCHLORIDE	Avenacy Inc.	8edd78a9-d762-4578-a610-28d6595f4bf3	2023-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211463 application number: ANDA211463

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1VXP4V453T	MELPHALAN HYDROCHLORIDE	3223-07-2	melphalan hydrochloride

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311487	melphalan 50 MG Injection	PSN	2254450e-4803-b947-e063-6394a90a4624	2
311487	melphalan 50 MG Injection	SCD	2254450e-4803-b947-e063-6394a90a4624	2
311487	melphalan (as melphalan hydrochloride) 50 MG Injection	SY	2254450e-4803-b947-e063-6394a90a4624	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84679-001-01	84679000101	1 KIT in 1 CARTON (84679-001-01) * 15 mL in 1 VIAL, SINGLE-DOSE (84679-002-01) * 10 mL in 1 VIAL, SINGLE-USE (84679-003-01)	1 kit	2024-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Melphalan Hydrochloride for Injection (For Intravenous Infusion)	Arthur Group LLC	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	2