IVRA

Product NDC: 60505-6414
11-digit product format: 605056414
Labeler code: 60505
Product ID: 60505-6414_81a31a0f-1d41-16fb-02d1-418357788c6c
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
2026-09-14 22:38:34	2026-08	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217110-001	IVRA	EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-08-18	`caaa826d4ba7…`
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
2026-09-14 22:38:34	2026-08	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217110-001	10537520	2036-06-29	Drug product	2023-09-01	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: IVRA
Listing expiration: 2027-12-31

Active Ingredients#

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

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

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