LENALIDOMIDE

Product NDC
0574-1410
11-digit product format
005741410
Labeler code
0574
Product ID
0574-1410_dffe719b-4f61-47e2-b71c-673322d487f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lenalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Padagis US LLC
Application
ANDA217265
Marketing category
ANDA
Marketing start
2026-01-31
Substance
LENALIDOMIDE
Active strength
10 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
A217265-001LENALIDOMIDELENALIDOMIDE2.5MGCAPSULE / ORALAB2024-02-22
A217265-002LENALIDOMIDELENALIDOMIDE5MGCAPSULE / ORALAB2024-02-22
A217265-003LENALIDOMIDELENALIDOMIDE10MGCAPSULE / ORALAB2024-02-22
A217265-004LENALIDOMIDELENALIDOMIDE15MGCAPSULE / ORALAB2024-02-22
A217265-005LENALIDOMIDELENALIDOMIDE20MGCAPSULE / ORALAB2024-02-22
A217265-006LENALIDOMIDELENALIDOMIDE25MGCAPSULE / ORALAB2024-02-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217265-001AB
A217265-002AB
A217265-003AB
A217265-004AB
A217265-005AB
A217265-006AB

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 · 96 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217265-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2024-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217265-002LENALIDOMIDE5MGCAPSULE / ORALAB2024-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217265-003LENALIDOMIDE10MGCAPSULE / ORALAB2024-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217265-004LENALIDOMIDE15MGCAPSULE / ORALAB2024-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217265-005LENALIDOMIDE20MGCAPSULE / ORALAB2024-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217265-006LENALIDOMIDE25MGCAPSULE / ORALAB2024-02-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217265-001LENALIDOMIDE2.5MGCAPSULE / ORAL2024-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217265-002LENALIDOMIDE5MGCAPSULE / ORAL2024-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217265-003LENALIDOMIDE10MGCAPSULE / ORAL2024-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217265-004LENALIDOMIDE15MGCAPSULE / ORAL2024-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217265-005LENALIDOMIDE20MGCAPSULE / ORAL2024-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217265-006LENALIDOMIDE25MGCAPSULE / ORAL2024-02-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A217265-001LENALIDOMIDE2.5MGCAPSULE / ORAL2024-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217265-002LENALIDOMIDE5MGCAPSULE / ORAL2024-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217265-003LENALIDOMIDE10MGCAPSULE / ORAL2024-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217265-004LENALIDOMIDE15MGCAPSULE / ORAL2024-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217265-005LENALIDOMIDE20MGCAPSULE / ORAL2024-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217265-006LENALIDOMIDE25MGCAPSULE / ORAL2024-02-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217265-001LENALIDOMIDE2.5MGCAPSULE / ORAL2024-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217265-002LENALIDOMIDE5MGCAPSULE / ORAL2024-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217265-003LENALIDOMIDE10MGCAPSULE / ORAL2024-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217265-004LENALIDOMIDE15MGCAPSULE / ORAL2024-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217265-005LENALIDOMIDE20MGCAPSULE / ORAL2024-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217265-006LENALIDOMIDE25MGCAPSULE / ORAL2024-02-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217265-001LENALIDOMIDE2.5MGCAPSULE / ORAL2024-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217265-002LENALIDOMIDE5MGCAPSULE / ORAL2024-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217265-003LENALIDOMIDE10MGCAPSULE / ORAL2024-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217265-004LENALIDOMIDE15MGCAPSULE / ORAL2024-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217265-005LENALIDOMIDE20MGCAPSULE / ORAL2024-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217265-006LENALIDOMIDE25MGCAPSULE / ORAL2024-02-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217265-001LENALIDOMIDE2.5MGCAPSULE / ORAL2024-02-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217265-002LENALIDOMIDE5MGCAPSULE / ORAL2024-02-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217265-003LENALIDOMIDE10MGCAPSULE / ORAL2024-02-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217265-004LENALIDOMIDE15MGCAPSULE / ORAL2024-02-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217265-005LENALIDOMIDE20MGCAPSULE / ORAL2024-02-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217265-006LENALIDOMIDE25MGCAPSULE / ORAL2024-02-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217265-001LENALIDOMIDE2.5MGCAPSULE / ORAL2024-02-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217265-002LENALIDOMIDE5MGCAPSULE / ORAL2024-02-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217265-003LENALIDOMIDE10MGCAPSULE / ORAL2024-02-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217265-004LENALIDOMIDE15MGCAPSULE / ORAL2024-02-222680178bc6a6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217265-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217265-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217265-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217265-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217265-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217265-006AB1011fe1cb6892…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217265-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217265-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217265-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217265-004AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217265-005AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217265-006AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217265-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217265-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217265-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217265-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217265-005AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217265-006AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217265-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217265-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217265-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217265-004AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217265-005AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217265-006AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217265-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217265-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217265-003AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217265-004AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217265-005AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217265-006AB16a51e52b5d6a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217265-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217265-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217265-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217265-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217265-005AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217265-006AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LENALIDOMIDE10 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
dffe719b-4f61-47e2-b71c-673322d487f5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba3b6b9d-cf27-aec0-3395-500a538c6915Product name620260306

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0574-1410-28LENALIDOMIDE28 in 1 BOTTLECAPSULE281

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-1410-28EA - Each0574-14107e2e9303-21e2-488f-8bad-b6d0db903ef612026-02-05

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
LENALIDOMIDELENALIDOMIDEPadagis US LLCdffe719b-4f61-47e2-b71c-673322d487f52025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217265
application number: ANDA217265
ndc (product): 0574-1410

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602910lenalidomide 10 MG Oral CapsulePSNdffe719b-4f61-47e2-b71c-673322d487f51
643712lenalidomide 15 MG Oral CapsulePSNdffe719b-4f61-47e2-b71c-673322d487f51
1242231lenalidomide 2.5 MG Oral CapsulePSNdffe719b-4f61-47e2-b71c-673322d487f51
1428947lenalidomide 20 MG Oral CapsulePSNdffe719b-4f61-47e2-b71c-673322d487f51
643720lenalidomide 25 MG Oral CapsulePSNdffe719b-4f61-47e2-b71c-673322d487f51
602912lenalidomide 5 MG Oral CapsulePSNdffe719b-4f61-47e2-b71c-673322d487f51
602910lenalidomide 10 MG Oral CapsuleSCDdffe719b-4f61-47e2-b71c-673322d487f51
643712lenalidomide 15 MG Oral CapsuleSCDdffe719b-4f61-47e2-b71c-673322d487f51
1242231lenalidomide 2.5 MG Oral CapsuleSCDdffe719b-4f61-47e2-b71c-673322d487f51
1428947lenalidomide 20 MG Oral CapsuleSCDdffe719b-4f61-47e2-b71c-673322d487f51
643720lenalidomide 25 MG Oral CapsuleSCDdffe719b-4f61-47e2-b71c-673322d487f51
602912lenalidomide 5 MG Oral CapsuleSCDdffe719b-4f61-47e2-b71c-673322d487f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0574-1410-280057414102828 CAPSULE in 1 BOTTLE (0574-1410-28) 28 capsule2026-01-31NoNoCurrent