FDA.reportPublic FDA data

Lenalidomide

Product NDC
82293-010
11-digit product format
822930010
Labeler code
82293
Product ID
82293-010_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
20 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 1.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A217281-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2024-09-11a50c72e98297…
2026-08-01 22:54:322026-06A217281-002LENALIDOMIDE5MGCAPSULE / ORALAB2024-09-11a50c72e98297…
2026-08-01 22:54:322026-06A217281-003LENALIDOMIDE10MGCAPSULE / ORALAB2024-09-11a50c72e98297…
2026-08-01 22:54:322026-06A217281-004LENALIDOMIDE15MGCAPSULE / ORALAB2024-09-11a50c72e98297…
2026-08-01 22:54:322026-06A217281-005LENALIDOMIDE20MGCAPSULE / ORALAB2024-09-11a50c72e98297…
2026-08-01 22:54:322026-06A217281-006LENALIDOMIDE25MGCAPSULE / ORALAB2024-09-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A217281-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A217281-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A217281-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A217281-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A217281-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A217281-006AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 82293-010

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LENALIDOMIDE20 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
82293-010-10Lenalidomide21 in 1 BOTTLECAPSULE211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82293-010-10EA - Each82293-0101966855b-b3e1-4e9c-a85a-8e7524a12dc412026-02-05

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
82293-010-108229300101021 CAPSULE in 1 BOTTLE (82293-010-10) 21 capsule2026-01-06NoNoCurrent