IVRA

Product NDC: 60505-6414
11-digit product format: 605056414
Labeler code: 60505
Product ID: 60505-6414_1aaa2d67-c709-f01c-026d-0eaa8f47c5d1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: melphalan HCl
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Apotex Corp
Application: NDA217110
Marketing category: NDA
Marketing start: 2025-05-09
Substance: MELPHALAN HYDROCHLORIDE
Active strength: 90 mg/mL
Pharmacologic classes: Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
N217110-001	IVRA	MELPHALAN HYDROCHLORIDE	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-08-18

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217110-001	10537520	2036-06-29		Drug product	2023-09-01

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217110-001	MELPHALAN HYDROCHLORIDE	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217110-001	MELPHALAN HYDROCHLORIDE	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217110-001	MELPHALAN HYDROCHLORIDE	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217110-001	MELPHALAN HYDROCHLORIDE	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217110-001	MELPHALAN HYDROCHLORIDE	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217110-001	MELPHALAN HYDROCHLORIDE	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217110-001	MELPHALAN HYDROCHLORIDE	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217110-001	MELPHALAN HYDROCHLORIDE	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: IVRA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MELPHALAN HYDROCHLORIDE	90 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1VXP4V453T	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2708998	Internal RxNorm lookup
2709003	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
c23e868a-dc62-2181-5099-76c9226602b2	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
60505-6414-1	IVRA	1 in 1 CARTON	INJECTION, SOLUTION	1		5
60505-6414-1	IVRA	3 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	3		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-6414-1	ML - Milliliter	60505-6414	9a4eb284-17d4-4e30-b9bb-f3e747620e61	1	2025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-6414	IVRA (MELPHALAN HCL) INJECTION, SOLUTION [APOTEX CORP]	4	Current NDC, 2 package rows	20250511_c23e868a-dc62-2181-5099-76c9226602b2.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IVRA	MELPHALAN HCL	Apotex Corp	c23e868a-dc62-2181-5099-76c9226602b2	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 217110 application number: NDA217110 ndc (product): 60505-6414

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
2709003	IVRA 90 MG/ML Injectable Solution	PSN	c23e868a-dc62-2181-5099-76c9226602b2	5
2708998	melphalan 90 MG/ML Injectable Solution	PSN	c23e868a-dc62-2181-5099-76c9226602b2	5
2709003	melphalan 90 MG/ML Injectable Solution [Ivra]	SBD	c23e868a-dc62-2181-5099-76c9226602b2	5
2708998	melphalan 90 MG/ML Injectable Solution	SCD	c23e868a-dc62-2181-5099-76c9226602b2	5
2709003	Ivra 90 MG (equivalent to melphalan hydrochloride 100.75 MG) per 1 ML Injectable Solution	SY	c23e868a-dc62-2181-5099-76c9226602b2	5
2708998	melphalan 90 MG (equivalent to melphalan hydrochloride 100.75 MG) per 1 ML Injectable Solution	SY	c23e868a-dc62-2181-5099-76c9226602b2	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
60505-6414-1	60505641401	1 VIAL, MULTI-DOSE in 1 CARTON (60505-6414-1) / 3 mL in 1 VIAL, MULTI-DOSE	2025-05-09	No	No	Current