Lenalidomide

Product NDC
82293-011
11-digit product format
822930011
Labeler code
82293
Product ID
82293-011_4531a3e4-1189-0276-e063-6394a90aedfd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lenalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Novugen Pharma (USA) LLC
Application
ANDA217281
Marketing category
ANDA
Marketing start
2026-01-06
Substance
LENALIDOMIDE
Active strength
25 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 42.

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 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217281-005LENALIDOMIDE20MGCAPSULE / ORALAB2024-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217281-006LENALIDOMIDE25MGCAPSULE / ORALAB2024-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217281-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2024-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217281-002LENALIDOMIDE5MGCAPSULE / ORALAB2024-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217281-003LENALIDOMIDE10MGCAPSULE / ORALAB2024-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217281-004LENALIDOMIDE15MGCAPSULE / ORALAB2024-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217281-005LENALIDOMIDE20MGCAPSULE / ORALAB2024-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217281-006LENALIDOMIDE25MGCAPSULE / ORALAB2024-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217281-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2024-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217281-002LENALIDOMIDE5MGCAPSULE / ORALAB2024-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217281-003LENALIDOMIDE10MGCAPSULE / ORALAB2024-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217281-004LENALIDOMIDE15MGCAPSULE / ORALAB2024-09-1103ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217281-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217281-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217281-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217281-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217281-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217281-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217281-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217281-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217281-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217281-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217281-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217281-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217281-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217281-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217281-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217281-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217281-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217281-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217281-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217281-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217281-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217281-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217281-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217281-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217281-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217281-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217281-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217281-004AB1fd3edfee7708…
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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LENALIDOMIDE25 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82293-011-10Lenalidomide21 in 1 BOTTLECAPSULE211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82293-011-10EA - Each82293-0118a9c12c8-9257-4709-ae76-9219c111e59f12026-02-05

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LenalidomideLENALIDOMIDENovugen Pharma (USA) LLC2166bbdf-eb12-4564-b9e4-b63ca21312bc2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217281
application number: ANDA217281
ndc (product): 82293-011

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
82293-011-108229300111021 CAPSULE in 1 BOTTLE (82293-011-10) 21 capsule2026-01-06NoNoCurrent