Lenalidomide

Product NDC: 70377-050
11-digit product format: 703770050
Labeler code: 70377
Product ID: 70377-050_356a3872-0df8-ff66-7ebc-ac8109186f86
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lenalidomide
Dosage form: CAPSULE
Route: ORAL
Labeler: BIOCON PHARMA INC.,
Application: ANDA215759
Marketing category: ANDA
Marketing start: 2025-03-03
Substance: LENALIDOMIDE
Active strength: 5 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 44.

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
A215759-001	LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2025-03-03
A215759-002	LENALIDOMIDE	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2025-03-03
A215759-003	LENALIDOMIDE	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2025-03-03
A215759-004	LENALIDOMIDE	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2025-03-03
A215759-005	LENALIDOMIDE	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2025-03-03
A215759-006	LENALIDOMIDE	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2025-03-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215759-001	AB
A215759-002	AB
A215759-003	AB
A215759-004	AB
A215759-005	AB
A215759-006	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 2 · 48 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
2026-10-15 13:18:30	2026-09	A215759-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2025-03-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A215759-002	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2025-03-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A215759-003	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2025-03-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A215759-004	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2025-03-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A215759-005	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2025-03-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A215759-006	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2025-03-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A215759-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2025-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215759-002	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2025-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215759-003	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2025-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215759-004	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2025-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215759-005	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2025-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215759-006	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2025-03-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215759-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2025-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215759-002	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2025-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215759-003	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2025-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215759-004	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2025-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215759-005	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2025-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215759-006	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2025-03-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215759-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2025-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215759-002	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2025-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215759-003	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2025-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215759-004	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2025-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215759-005	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2025-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215759-006	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2025-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215759-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2025-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215759-002	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2025-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215759-003	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2025-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215759-004	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2025-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215759-005	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2025-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215759-006	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2025-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215759-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2025-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215759-002	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2025-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215759-003	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2025-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215759-004	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2025-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215759-005	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2025-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215759-006	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2025-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215759-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2025-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215759-002	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2025-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215759-003	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2025-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215759-004	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2025-03-03	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A215759-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A215759-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A215759-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A215759-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A215759-005	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A215759-006	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A215759-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215759-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215759-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215759-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215759-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215759-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215759-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215759-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215759-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215759-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215759-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215759-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215759-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215759-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215759-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215759-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215759-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215759-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215759-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215759-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215759-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215759-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215759-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215759-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215759-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215759-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215759-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215759-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215759-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215759-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215759-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215759-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215759-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215759-004	AB	1	`fd3edfee7708…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LENALIDOMIDE	5 mg/1

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
70377-050-12	Lenalidomide	100 in 1 BOTTLE	CAPSULE	100		9
70377-050-13	Lenalidomide	28 in 1 BOTTLE	CAPSULE	28		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70377-050-13	EA - Each	70377-050	0793123d-4e66-4a2e-a903-a2c1abe48f53	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70377-050	LENALIDOMIDE CAPSULE [BIOCON PHARMA INC.,]	9	Current NDC, 2 package rows	20250306_ed7a3099-ce31-4865-b212-358d9ff6261b.zip

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	ed7a3099-ce31-4865-b212-358d9ff6261b	9
643712	lenalidomide 15 MG Oral Capsule	PSN	ed7a3099-ce31-4865-b212-358d9ff6261b	9
1242231	lenalidomide 2.5 MG Oral Capsule	PSN	ed7a3099-ce31-4865-b212-358d9ff6261b	9
1428947	lenalidomide 20 MG Oral Capsule	PSN	ed7a3099-ce31-4865-b212-358d9ff6261b	9
643720	lenalidomide 25 MG Oral Capsule	PSN	ed7a3099-ce31-4865-b212-358d9ff6261b	9
602912	lenalidomide 5 MG Oral Capsule	PSN	ed7a3099-ce31-4865-b212-358d9ff6261b	9
602910	lenalidomide 10 MG Oral Capsule	SCD	ed7a3099-ce31-4865-b212-358d9ff6261b	9
643712	lenalidomide 15 MG Oral Capsule	SCD	ed7a3099-ce31-4865-b212-358d9ff6261b	9
1242231	lenalidomide 2.5 MG Oral Capsule	SCD	ed7a3099-ce31-4865-b212-358d9ff6261b	9
1428947	lenalidomide 20 MG Oral Capsule	SCD	ed7a3099-ce31-4865-b212-358d9ff6261b	9
643720	lenalidomide 25 MG Oral Capsule	SCD	ed7a3099-ce31-4865-b212-358d9ff6261b	9
602912	lenalidomide 5 MG Oral Capsule	SCD	ed7a3099-ce31-4865-b212-358d9ff6261b	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70377-050-12	70377005012	100 CAPSULE in 1 BOTTLE (70377-050-12)	100 capsule	2025-03-03	No	No	Current
70377-050-13	70377005013	28 CAPSULE in 1 BOTTLE (70377-050-13)	28 capsule	2025-03-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lenalidomide	BIOCON PHARMA INC., \| BIOCON PHARMA LIMITED	2025-03-03	HUMAN PRESCRIPTION DRUG LABEL	10