LENALIDOMIDE

Product NDC: 76282-696
11-digit product format: 762820696
Labeler code: 76282
Product ID: 76282-696_ecb5abfb-3a17-4235-a7fe-0183c5586738
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LENALIDOMIDE
Dosage form: CAPSULE
Route: ORAL
Labeler: EXELAN PHARMACEUTICALS INC.
Application: ANDA214618
Marketing category: ANDA
Marketing start: 2024-06-10
Substance: LENALIDOMIDE
Active strength: 2.5 mg/1
Pharmacologic classes: Thalidomide Analog [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 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
A214618-001	LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB		2023-03-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214618-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214618-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2023-03-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214618-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214618-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214618-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214618-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214618-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214618-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214618-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214618-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214618-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214618-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214618-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214618-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214618-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214618-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214618-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214618-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214618-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214618-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214618-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214618-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214618-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214618-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214618-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214618-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214618-001	AB	1	`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: LENALIDOMIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LENALIDOMIDE	2.5 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1242231	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
85f5db5d-8f76-46f6-b975-6acda8c4b2c8	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
76282-696-48	LENALIDOMIDE	28 in 1 BOTTLE	CAPSULE	28		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76282-696-48	EA - Each	76282-696	3c968522-0d66-438d-bd35-dc35480c21ba	1	2024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76282-696	LENALIDOMIDE CAPSULE [EXELAN PHARMACEUTICALS INC.]	1	Current NDC, 1 package rows	20240620_85f5db5d-8f76-46f6-b975-6acda8c4b2c8.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LENALIDOMIDE	LENALIDOMIDE	EXELAN PHARMACEUTICALS INC.	85f5db5d-8f76-46f6-b975-6acda8c4b2c8	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214618 application number: ANDA214618 ndc (product): 76282-696
Lenalidomide	LENALIDOMIDE	Cipla USA Inc.	96df285d-dd13-4083-b2c6-e5c799e7587b	2022-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214618 application number: ANDA214618

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
1242231	lenalidomide 2.5 MG Oral Capsule	PSN	85f5db5d-8f76-46f6-b975-6acda8c4b2c8	1
1242231	lenalidomide 2.5 MG Oral Capsule	SCD	85f5db5d-8f76-46f6-b975-6acda8c4b2c8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76282-696-48	76282069648	28 CAPSULE in 1 BOTTLE (76282-696-48)	28 capsule	2024-06-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LENALIDOMIDE	EXELAN PHARMACEUTICALS INC. \| Cipla USA Inc. \| Genvion Corporation \| CIPLA LIMITED BOMMASANDRA	2024-06-12	HUMAN PRESCRIPTION DRUG LABEL	1