Lenalidomide

Product NDC
82293-034
11-digit product format
822930034
Labeler code
82293
Product ID
82293-034_5e7ce385-737e-736a-e063-6294a90aa87a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lenalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Novugen Pharma (USA) LLC
Application
ANDA217281
Marketing category
ANDA
Marketing start
2026-04-10
Substance
LENALIDOMIDE
Active strength
2.5 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217281-001LENALIDOMIDELENALIDOMIDE2.5MGCAPSULE / ORALAB2024-09-11
A217281-002LENALIDOMIDELENALIDOMIDE5MGCAPSULE / ORALAB2024-09-11
A217281-003LENALIDOMIDELENALIDOMIDE10MGCAPSULE / ORALAB2024-09-11
A217281-004LENALIDOMIDELENALIDOMIDE15MGCAPSULE / ORALAB2024-09-11
A217281-005LENALIDOMIDELENALIDOMIDE20MGCAPSULE / ORALAB2024-09-11
A217281-006LENALIDOMIDELENALIDOMIDE25MGCAPSULE / ORALAB2024-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217281-001AB
A217281-002AB
A217281-003AB
A217281-004AB
A217281-005AB
A217281-006AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A217281-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2024-09-11c2088c7a36db…
2026-10-15 13:18:302026-09A217281-002LENALIDOMIDE5MGCAPSULE / ORALAB2024-09-11c2088c7a36db…
2026-10-15 13:18:302026-09A217281-003LENALIDOMIDE10MGCAPSULE / ORALAB2024-09-11c2088c7a36db…
2026-10-15 13:18:302026-09A217281-004LENALIDOMIDE15MGCAPSULE / ORALAB2024-09-11c2088c7a36db…
2026-10-15 13:18:302026-09A217281-005LENALIDOMIDE20MGCAPSULE / ORALAB2024-09-11c2088c7a36db…
2026-10-15 13:18:302026-09A217281-006LENALIDOMIDE25MGCAPSULE / ORALAB2024-09-11c2088c7a36db…
2026-09-14 22:38:342026-08A217281-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2024-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A217281-002LENALIDOMIDE5MGCAPSULE / ORALAB2024-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A217281-003LENALIDOMIDE10MGCAPSULE / ORALAB2024-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A217281-004LENALIDOMIDE15MGCAPSULE / ORALAB2024-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A217281-005LENALIDOMIDE20MGCAPSULE / ORALAB2024-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A217281-006LENALIDOMIDE25MGCAPSULE / ORALAB2024-09-1184e616aacf4f…
2026-08-18 06:07:402026-07A217281-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2024-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A217281-002LENALIDOMIDE5MGCAPSULE / ORALAB2024-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A217281-003LENALIDOMIDE10MGCAPSULE / ORALAB2024-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A217281-004LENALIDOMIDE15MGCAPSULE / ORALAB2024-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A217281-005LENALIDOMIDE20MGCAPSULE / ORALAB2024-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A217281-006LENALIDOMIDE25MGCAPSULE / ORALAB2024-09-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217281-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2024-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217281-002LENALIDOMIDE5MGCAPSULE / ORALAB2024-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217281-003LENALIDOMIDE10MGCAPSULE / ORALAB2024-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217281-004LENALIDOMIDE15MGCAPSULE / ORALAB2024-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217281-005LENALIDOMIDE20MGCAPSULE / ORALAB2024-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217281-006LENALIDOMIDE25MGCAPSULE / ORALAB2024-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217281-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2024-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217281-002LENALIDOMIDE5MGCAPSULE / ORALAB2024-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217281-003LENALIDOMIDE10MGCAPSULE / ORALAB2024-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217281-004LENALIDOMIDE15MGCAPSULE / ORALAB2024-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217281-005LENALIDOMIDE20MGCAPSULE / ORALAB2024-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217281-006LENALIDOMIDE25MGCAPSULE / ORALAB2024-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217281-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2024-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217281-002LENALIDOMIDE5MGCAPSULE / ORALAB2024-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217281-003LENALIDOMIDE10MGCAPSULE / ORALAB2024-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217281-004LENALIDOMIDE15MGCAPSULE / ORALAB2024-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217281-005LENALIDOMIDE20MGCAPSULE / ORALAB2024-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217281-006LENALIDOMIDE25MGCAPSULE / ORALAB2024-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217281-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2024-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217281-002LENALIDOMIDE5MGCAPSULE / ORALAB2024-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217281-003LENALIDOMIDE10MGCAPSULE / ORALAB2024-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217281-004LENALIDOMIDE15MGCAPSULE / ORALAB2024-09-11fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217281-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217281-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217281-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217281-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217281-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217281-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217281-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217281-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217281-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217281-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217281-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217281-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217281-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217281-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217281-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217281-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217281-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217281-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217281-005AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217281-006AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217281-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217281-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217281-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217281-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217281-005AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217281-006AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217281-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217281-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217281-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217281-004AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217281-005AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217281-006AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217281-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217281-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217281-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217281-004AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217281-005AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217281-006AB1d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217281-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217281-002AB1a50c72e98297…

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
IngredientStrength
LENALIDOMIDE2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F0P408N6V4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
602910Internal RxNorm lookup
602912Internal RxNorm lookup
643712Internal RxNorm lookup
643720Internal RxNorm lookup
1242231Internal RxNorm lookup
1428947Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2166bbdf-eb12-4564-b9e4-b63ca21312bcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba3b6b9d-cf27-aec0-3395-500a538c6915Product name620260306
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602910lenalidomide 10 MG Oral CapsulePSN2166bbdf-eb12-4564-b9e4-b63ca21312bc1
643712lenalidomide 15 MG Oral CapsulePSN2166bbdf-eb12-4564-b9e4-b63ca21312bc1
1242231lenalidomide 2.5 MG Oral CapsulePSN2166bbdf-eb12-4564-b9e4-b63ca21312bc1
1428947lenalidomide 20 MG Oral CapsulePSN2166bbdf-eb12-4564-b9e4-b63ca21312bc1
643720lenalidomide 25 MG Oral CapsulePSN2166bbdf-eb12-4564-b9e4-b63ca21312bc1
602912lenalidomide 5 MG Oral CapsulePSN2166bbdf-eb12-4564-b9e4-b63ca21312bc1
602910lenalidomide 10 MG Oral CapsuleSCD2166bbdf-eb12-4564-b9e4-b63ca21312bc1
643712lenalidomide 15 MG Oral CapsuleSCD2166bbdf-eb12-4564-b9e4-b63ca21312bc1
1242231lenalidomide 2.5 MG Oral CapsuleSCD2166bbdf-eb12-4564-b9e4-b63ca21312bc1
1428947lenalidomide 20 MG Oral CapsuleSCD2166bbdf-eb12-4564-b9e4-b63ca21312bc1
643720lenalidomide 25 MG Oral CapsuleSCD2166bbdf-eb12-4564-b9e4-b63ca21312bc1
602912lenalidomide 5 MG Oral CapsuleSCD2166bbdf-eb12-4564-b9e4-b63ca21312bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82293-034-108229300341028 CAPSULE in 1 BOTTLE (82293-034-10) 28 capsule2026-04-10NoNoCurrent