Melphalan hydrochloride

Product NDC: 71288-112
11-digit product format: 712880112
Labeler code: 71288
Product ID: 71288-112_30f168d8-65a3-44d7-971c-462f1ff41d6e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Melphalan hydrochloride
Dosage form: KIT
Route: INTRAVENOUS
Labeler: Meitheal Pharmaceuticals Inc.
Application: ANDA209826
Marketing category: ANDA
Marketing start: 2019-06-30
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2023-12-31
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	71288-112		D	Discontinued by firm		2026-08-11
excluded package	package	71288-112	71288-112-90	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 · 4 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	71288-112-90	`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	71288-112-90	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A209826-001	MELPHALAN HYDROCHLORIDE	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP		2019-05-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209826-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209826-001	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-05-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209826-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209826-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209826-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209826-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209826-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209826-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209826-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209826-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209826-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209826-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209826-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209826-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209826-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209826-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209826-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209826-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209826-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209826-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209826-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209826-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209826-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209826-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209826-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209826-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209826-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209826-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209826-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209826-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209826-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209826-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209826-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209826-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209826-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209826-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209826-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209826-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209826-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209826-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209826-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209826-001	AP	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71288-112-90	EA - Each	71288-112	ece0ef07-92ca-45f9-bf4b-73cbbe679405	1	2019-08-06

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	Sagent Pharmaceuticals	35f3d9fe-3c2f-4362-9d40-cdab014cac38	2024-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209826 application number: ANDA209826
Melphalan hydrochloride	MELPHALAN HYDROCHLORIDE	Fosun Pharma USA Inc	54712714-744d-4deb-83b2-694da49a9272	2019-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209826 application number: ANDA209826
Melphalan hydrochloride	MELPHALAN HYDROCHLORIDE	Gland Pharma Limited	ea7fbf4e-4980-4bb4-bac9-99eb6f633ba0	2019-06-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209826 application number: ANDA209826

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71288-112-90	71288011290	1 KIT in 1 CARTON (71288-112-90) * 10 mL in 1 VIAL, SINGLE-DOSE (71288-111-10) * 10 mL in 1 VIAL, SINGLE-USE (71288-110-10)	1 kit	2019-06-30	2025-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Melphalan Hydrochloride for Injection (For Intravenous Infusion)	Meitheal Pharmaceuticals Inc.	2024-03-19	HUMAN PRESCRIPTION DRUG LABEL	3