Proleukin

Product NDC: 65483-116
11-digit product format: 654830116
Labeler code: 65483
Product ID: 65483-116_b50616d7-928a-4c4b-96fe-b17d0fcc52c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: aldesleukin
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Prometheus Laboratories Inc.
Application: BLA103293
Marketing category: BLA
Marketing start: 1992-05-05
Marketing end: 0000-00-00
Substance: ALDESLEUKIN
Active strength: 1 mg/mL
Pharmacologic classes: Increased Lymphocyte Activation [PE],Increased Lymphocyte Cell Production [PE],Interleukin-2 [CS],Lymphocyte Growth Factor [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	65483-116		I	Inactivated by FDA		2026-08-17
excluded package	package	65483-116	65483-116-07	I	Inactivated by FDA		2026-08-17

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 · 38 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	65483-116-07	`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	65483-116-07	`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	65483-116-07	`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	65483-116-07	`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	65483-116-07	`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	65483-116-07	`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	65483-116-07	`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	65483-116-07	`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	65483-116-07	`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	65483-116-07	`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	65483-116-07	`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	65483-116-07	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	65483-116-07	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	65483-116-07	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	65483-116-07	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	65483-116-07	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	65483-116-07	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	65483-116-07	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	65483-116-07	`8dfbde2a14a4…`	`c9ff85d89658…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65483-116-07	2021-01-29	C162847	48780-1	ba0f9c33-3c00-a910-e053-dadaa90a0b85	PROLEUKIN®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65483-116-07	Proleukin	1 mL in 1 VIAL, SINGLE-USE	INJECTION, POWDER, LYOPHILIZED,	1		15
65483-116-07	Proleukin	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65483-116-07	EA - Each	65483-116	a2f43c89-5e56-451b-8741-e3101f8607eb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
aldesleukin	ACTIVE INGREDIENT	M89N0Q7EQR	PROLEUKIN (ALDESLEUKIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PROMETHEUS LABORATORIES INC.]	13
aldesleukin	ACTIVE MOIETY	M89N0Q7EQR	PROLEUKIN (ALDESLEUKIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PROMETHEUS LABORATORIES INC.]	13
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PROLEUKIN (ALDESLEUKIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PROMETHEUS LABORATORIES INC.]	13
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PROLEUKIN (ALDESLEUKIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PROMETHEUS LABORATORIES INC.]	13
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	PROLEUKIN (ALDESLEUKIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PROMETHEUS LABORATORIES INC.]	13
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	PROLEUKIN (ALDESLEUKIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PROMETHEUS LABORATORIES INC.]	13
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROLEUKIN (ALDESLEUKIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PROMETHEUS LABORATORIES INC.]	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65483-116	PROLEUKIN (ALDESLEUKIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PROMETHEUS LABORATORIES INC.]	15	Legacy NDC, 2 package rows	20190607_4e2b687e-47f2-4f3c-80ab-e3224befffca.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
PROLEUKIN	ALDESLEUKIN	Iovance Biotherapeutics, Inc	f3c516ad-d405-4fbe-af6a-962080dbfa7d	2024-12-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA103293

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103293	Proleukin	aldesleukin	351(a)	Rx	2026-07-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M89N0Q7EQR	ALDESLEUKIN	110942-02-4	ALDESLEUKIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
307816	aldesleukin 22,000,000 UNT Injection	PSN	4e2b687e-47f2-4f3c-80ab-e3224befffca	15
105648	Proleukin 22,000,000 UNT Injection	PSN	4e2b687e-47f2-4f3c-80ab-e3224befffca	15
105648	aldesleukin 22000000 UNT Injection [Proleukin]	SBD	4e2b687e-47f2-4f3c-80ab-e3224befffca	15
307816	aldesleukin 22000000 UNT Injection	SCD	4e2b687e-47f2-4f3c-80ab-e3224befffca	15
307816	aldesleukin 1.3 MG Injection	SY	4e2b687e-47f2-4f3c-80ab-e3224befffca	15
307816	aldesleukin 22,000,000 UNT Injection	SY	4e2b687e-47f2-4f3c-80ab-e3224befffca	15
105648	Proleukin 1.3 MG Injection	SY	4e2b687e-47f2-4f3c-80ab-e3224befffca	15
105648	Proleukin 22000000 UNT Injection	SY	4e2b687e-47f2-4f3c-80ab-e3224befffca	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
65483-116-07	65483011607	1 mL in 1 VIAL, SINGLE-USE	1 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROLEUKIN®	Prometheus Laboratories Inc. \| Boehringer-Ingleheim \| Catalent U.K. Packaging Limited	2019-05-23	HUMAN PRESCRIPTION DRUG LABEL	15