Lenalidomide

Product NDC: 16729-694
11-digit product format: 167290694
Labeler code: 16729
Product ID: 16729-694_513e8d33-e9bf-df2b-e063-6394a90a1ee9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lenalidomide
Dosage form: CAPSULE
Route: ORAL
Labeler: Accord Healthcare Inc.
Application: ANDA218872
Marketing category: ANDA
Marketing start: 2026-02-17
Substance: LENALIDOMIDE
Active strength: 10 mg/1
Pharmacologic classes: Thalidomide Analog [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 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
A218872-001	LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2025-11-14
A218872-002	LENALIDOMIDE	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2025-11-14
A218872-003	LENALIDOMIDE	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2025-11-14
A218872-004	LENALIDOMIDE	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2025-11-14
A218872-005	LENALIDOMIDE	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2025-11-14
A218872-006	LENALIDOMIDE	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2025-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218872-001	AB
A218872-002	AB
A218872-003	AB
A218872-004	AB
A218872-005	AB
A218872-006	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.

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	A218872-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2025-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218872-002	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2025-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218872-003	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2025-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218872-004	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2025-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218872-005	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2025-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218872-006	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2025-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218872-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2025-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218872-002	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2025-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218872-003	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2025-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218872-004	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2025-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218872-005	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2025-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218872-006	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2025-11-14	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218872-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2025-11-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218872-002	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2025-11-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218872-003	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2025-11-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218872-004	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2025-11-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218872-005	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2025-11-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218872-006	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2025-11-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A218872-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218872-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218872-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218872-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218872-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218872-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218872-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218872-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218872-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218872-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218872-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218872-006	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218872-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218872-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218872-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218872-004	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218872-005	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218872-006	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LENALIDOMIDE	10 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
9c414531-a3bf-455a-aca7-9e716f42099a	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
16729-694-09	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
16729-694-09	EA - Each	16729-694	7c474d0f-9c71-4990-911a-c166e1bfcdd2	1	2026-03-17

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	Accord Healthcare Inc.	9c414531-a3bf-455a-aca7-9e716f42099a	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218872 application number: ANDA218872 ndc (product): 16729-694

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	9c414531-a3bf-455a-aca7-9e716f42099a	6
643712	lenalidomide 15 MG Oral Capsule	PSN	9c414531-a3bf-455a-aca7-9e716f42099a	6
1242231	lenalidomide 2.5 MG Oral Capsule	PSN	9c414531-a3bf-455a-aca7-9e716f42099a	6
1428947	lenalidomide 20 MG Oral Capsule	PSN	9c414531-a3bf-455a-aca7-9e716f42099a	6
643720	lenalidomide 25 MG Oral Capsule	PSN	9c414531-a3bf-455a-aca7-9e716f42099a	6
602912	lenalidomide 5 MG Oral Capsule	PSN	9c414531-a3bf-455a-aca7-9e716f42099a	6
602910	lenalidomide 10 MG Oral Capsule	SCD	9c414531-a3bf-455a-aca7-9e716f42099a	6
643712	lenalidomide 15 MG Oral Capsule	SCD	9c414531-a3bf-455a-aca7-9e716f42099a	6
1242231	lenalidomide 2.5 MG Oral Capsule	SCD	9c414531-a3bf-455a-aca7-9e716f42099a	6
1428947	lenalidomide 20 MG Oral Capsule	SCD	9c414531-a3bf-455a-aca7-9e716f42099a	6
643720	lenalidomide 25 MG Oral Capsule	SCD	9c414531-a3bf-455a-aca7-9e716f42099a	6
602912	lenalidomide 5 MG Oral Capsule	SCD	9c414531-a3bf-455a-aca7-9e716f42099a	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
16729-694-09	16729069409	28 CAPSULE in 1 BOTTLE (16729-694-09)	28 capsule	2026-02-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lenalidomide	Accord Healthcare Inc. \| Reliance Life Sciences Pvt. Ltd.	2026-05-07	HUMAN PRESCRIPTION DRUG LABEL	6