Lenalidomide

Product NDC: 60505-4533
11-digit product format: 605054533
Labeler code: 60505
Product ID: 60505-4533_0ac7ca79-cd31-4bc1-ddc6-a90c9efcc1c4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lenalidomide
Dosage form: CAPSULE
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA211022
Marketing category: ANDA
Marketing start: 2022-09-06
Substance: LENALIDOMIDE
Active strength: 5 mg/1
Pharmacologic classes: Thalidomide Analog [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60505-4533	60505-4533-1	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211022-001	LENALIDOMIDE	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2022-08-30
A211022-002	LENALIDOMIDE	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2022-08-30
A211022-003	LENALIDOMIDE	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2022-08-30
A211022-004	LENALIDOMIDE	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2022-08-30
A211022-005	LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-07
A211022-006	LENALIDOMIDE	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2023-03-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A211022-001	AB
A211022-002	AB
A211022-003	AB
A211022-004	AB
A211022-005	AB
A211022-006	AB

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 4 · 154 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	A211022-001	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2022-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211022-002	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2022-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211022-003	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2022-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211022-004	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2022-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211022-005	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211022-006	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2023-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211022-001	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2022-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211022-002	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2022-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211022-003	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2022-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211022-004	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2022-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211022-005	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211022-006	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2023-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211022-001	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2022-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211022-002	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2022-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211022-003	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2022-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211022-004	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2022-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211022-005	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211022-006	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2023-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211022-001	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2022-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211022-002	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2022-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211022-003	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2022-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211022-004	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2022-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211022-005	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211022-006	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2023-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211022-001	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2022-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211022-002	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2022-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211022-003	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2022-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211022-004	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2022-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211022-005	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211022-006	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2023-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211022-001	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2022-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211022-002	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2022-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211022-003	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2022-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211022-004	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2022-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211022-005	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211022-006	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2023-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211022-001	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2022-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211022-002	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2022-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211022-003	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2022-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211022-004	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2022-08-30	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 154 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	A211022-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211022-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211022-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211022-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211022-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211022-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211022-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211022-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211022-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211022-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211022-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211022-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211022-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211022-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211022-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211022-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211022-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211022-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211022-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211022-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211022-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211022-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211022-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211022-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211022-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211022-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211022-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211022-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211022-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211022-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211022-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211022-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211022-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211022-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211022-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211022-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211022-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211022-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211022-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211022-004	AB	1	`2680178bc6a6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LENALIDOMIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F0P408N6V4	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
602910	Internal RxNorm lookup
602912	Internal RxNorm lookup
643712	Internal RxNorm lookup
643720	Internal RxNorm lookup
1242231	Internal RxNorm lookup
1428947	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
9943e098-20b0-dbb3-af12-7816eedd3f70	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba3b6b9d-cf27-aec0-3395-500a538c6915	Product name	6	20260306

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60505-4533-1	Lenalidomide	100 in 1 BOTTLE	CAPSULE	100		6
60505-4533-2	Lenalidomide	28 in 1 BOTTLE	CAPSULE	28		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-4533-2	EA - Each	60505-4533	ae00a5af-c0cd-45a4-988b-0a08947cfda0	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-4533	LENALIDOMIDE CAPSULE [APOTEX CORP.]	5	Current NDC, Legacy NDC, 2 package rows	20240704_9943e098-20b0-dbb3-af12-7816eedd3f70.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
Lenalidomide	LENALIDOMIDE	Apotex Corp.	9943e098-20b0-dbb3-af12-7816eedd3f70	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211022 application number: ANDA211022 ndc (product): 60505-4533

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F0P408N6V4	LENALIDOMIDE	191732-72-6	LENALIDOMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
602910	lenalidomide 10 MG Oral Capsule	PSN	9943e098-20b0-dbb3-af12-7816eedd3f70	6
643712	lenalidomide 15 MG Oral Capsule	PSN	9943e098-20b0-dbb3-af12-7816eedd3f70	6
1242231	lenalidomide 2.5 MG Oral Capsule	PSN	9943e098-20b0-dbb3-af12-7816eedd3f70	6
1428947	lenalidomide 20 MG Oral Capsule	PSN	9943e098-20b0-dbb3-af12-7816eedd3f70	6
643720	lenalidomide 25 MG Oral Capsule	PSN	9943e098-20b0-dbb3-af12-7816eedd3f70	6
602912	lenalidomide 5 MG Oral Capsule	PSN	9943e098-20b0-dbb3-af12-7816eedd3f70	6
602910	lenalidomide 10 MG Oral Capsule	SCD	9943e098-20b0-dbb3-af12-7816eedd3f70	6
643712	lenalidomide 15 MG Oral Capsule	SCD	9943e098-20b0-dbb3-af12-7816eedd3f70	6
1242231	lenalidomide 2.5 MG Oral Capsule	SCD	9943e098-20b0-dbb3-af12-7816eedd3f70	6
1428947	lenalidomide 20 MG Oral Capsule	SCD	9943e098-20b0-dbb3-af12-7816eedd3f70	6
643720	lenalidomide 25 MG Oral Capsule	SCD	9943e098-20b0-dbb3-af12-7816eedd3f70	6
602912	lenalidomide 5 MG Oral Capsule	SCD	9943e098-20b0-dbb3-af12-7816eedd3f70	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-4533-1	60505453301	100 CAPSULE in 1 BOTTLE (60505-4533-1)	100 capsule	2022-09-06	0000-00-00	No	No	Current
60505-4533-2	60505453302	28 CAPSULE in 1 BOTTLE (60505-4533-2)	28 capsule	2022-09-06	0000-00-00	No	No	Current