LENALIDOMIDE

Product NDC
31722-261
11-digit product format
317220261
Labeler code
31722
Product ID
31722-261_1f172b43-d7bb-0805-e063-6394a90ab37d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LENALIDOMIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA212414
Marketing category
ANDA
Marketing start
2023-05-11
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
A212414-001LENALIDOMIDELENALIDOMIDE2.5MGCAPSULE / ORALAB2023-05-11
A212414-002LENALIDOMIDELENALIDOMIDE5MGCAPSULE / ORALAB2023-05-11
A212414-003LENALIDOMIDELENALIDOMIDE10MGCAPSULE / ORALAB2023-05-11
A212414-004LENALIDOMIDELENALIDOMIDE15MGCAPSULE / ORALAB2023-05-11
A212414-005LENALIDOMIDELENALIDOMIDE20MGCAPSULE / ORALAB2023-05-11
A212414-006LENALIDOMIDELENALIDOMIDE25MGCAPSULE / ORALAB2023-05-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212414-001AB
A212414-002AB
A212414-003AB
A212414-004AB
A212414-005AB
A212414-006AB

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 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212414-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212414-002LENALIDOMIDE5MGCAPSULE / ORALAB2023-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212414-003LENALIDOMIDE10MGCAPSULE / ORALAB2023-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212414-004LENALIDOMIDE15MGCAPSULE / ORALAB2023-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212414-005LENALIDOMIDE20MGCAPSULE / ORALAB2023-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212414-006LENALIDOMIDE25MGCAPSULE / ORALAB2023-05-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212414-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212414-002LENALIDOMIDE5MGCAPSULE / ORALAB2023-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212414-003LENALIDOMIDE10MGCAPSULE / ORALAB2023-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212414-004LENALIDOMIDE15MGCAPSULE / ORALAB2023-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212414-005LENALIDOMIDE20MGCAPSULE / ORALAB2023-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212414-006LENALIDOMIDE25MGCAPSULE / ORALAB2023-05-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212414-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212414-002LENALIDOMIDE5MGCAPSULE / ORALAB2023-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212414-003LENALIDOMIDE10MGCAPSULE / ORALAB2023-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212414-004LENALIDOMIDE15MGCAPSULE / ORALAB2023-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212414-005LENALIDOMIDE20MGCAPSULE / ORALAB2023-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212414-006LENALIDOMIDE25MGCAPSULE / ORALAB2023-05-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212414-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212414-002LENALIDOMIDE5MGCAPSULE / ORALAB2023-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212414-003LENALIDOMIDE10MGCAPSULE / ORALAB2023-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212414-004LENALIDOMIDE15MGCAPSULE / ORALAB2023-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212414-005LENALIDOMIDE20MGCAPSULE / ORALAB2023-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212414-006LENALIDOMIDE25MGCAPSULE / ORALAB2023-05-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212414-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212414-002LENALIDOMIDE5MGCAPSULE / ORALAB2023-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212414-003LENALIDOMIDE10MGCAPSULE / ORALAB2023-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212414-004LENALIDOMIDE15MGCAPSULE / ORALAB2023-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212414-005LENALIDOMIDE20MGCAPSULE / ORALAB2023-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212414-006LENALIDOMIDE25MGCAPSULE / ORALAB2023-05-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212414-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212414-002LENALIDOMIDE5MGCAPSULE / ORALAB2023-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212414-003LENALIDOMIDE10MGCAPSULE / ORALAB2023-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212414-004LENALIDOMIDE15MGCAPSULE / ORALAB2023-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212414-005LENALIDOMIDE20MGCAPSULE / ORALAB2023-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212414-006LENALIDOMIDE25MGCAPSULE / ORALAB2023-05-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212414-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-05-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212414-002LENALIDOMIDE5MGCAPSULE / ORALAB2023-05-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212414-003LENALIDOMIDE10MGCAPSULE / ORALAB2023-05-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212414-004LENALIDOMIDE15MGCAPSULE / ORALAB2023-05-112680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212414-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212414-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212414-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212414-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212414-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212414-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212414-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212414-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212414-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212414-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212414-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212414-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212414-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212414-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212414-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212414-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212414-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212414-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212414-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212414-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212414-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212414-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212414-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212414-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212414-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212414-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212414-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212414-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212414-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212414-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212414-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212414-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212414-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212414-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212414-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212414-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212414-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212414-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212414-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212414-004AB12680178bc6a6…

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
f27092f3-3977-4f4a-b214-45309e136e46Available 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
31722-261-01LENALIDOMIDE100 in 1 BOTTLECAPSULE1003
31722-261-21LENALIDOMIDE21 in 1 BOTTLECAPSULE213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-261-21EA - Each31722-26127e474d4-2c7d-40b0-b59e-7cafedc8778812023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-261LENALIDOMIDE (LENALIDOMIDE) CAPSULE [CAMBER PHARMACEUTICALS, INC.]3Current NDC, 2 package rows20240808_f27092f3-3977-4f4a-b214-45309e136e46.zip

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
LENALIDOMIDELENALIDOMIDECamber Pharmaceuticals, Inc.f27092f3-3977-4f4a-b214-45309e136e462024-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212414
application number: ANDA212414
ndc (product): 31722-261

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602910lenalidomide 10 MG Oral CapsulePSNf27092f3-3977-4f4a-b214-45309e136e463
643712lenalidomide 15 MG Oral CapsulePSNf27092f3-3977-4f4a-b214-45309e136e463
1242231lenalidomide 2.5 MG Oral CapsulePSNf27092f3-3977-4f4a-b214-45309e136e463
1428947lenalidomide 20 MG Oral CapsulePSNf27092f3-3977-4f4a-b214-45309e136e463
643720lenalidomide 25 MG Oral CapsulePSNf27092f3-3977-4f4a-b214-45309e136e463
602912lenalidomide 5 MG Oral CapsulePSNf27092f3-3977-4f4a-b214-45309e136e463
602910lenalidomide 10 MG Oral CapsuleSCDf27092f3-3977-4f4a-b214-45309e136e463
643712lenalidomide 15 MG Oral CapsuleSCDf27092f3-3977-4f4a-b214-45309e136e463
1242231lenalidomide 2.5 MG Oral CapsuleSCDf27092f3-3977-4f4a-b214-45309e136e463
1428947lenalidomide 20 MG Oral CapsuleSCDf27092f3-3977-4f4a-b214-45309e136e463
643720lenalidomide 25 MG Oral CapsuleSCDf27092f3-3977-4f4a-b214-45309e136e463
602912lenalidomide 5 MG Oral CapsuleSCDf27092f3-3977-4f4a-b214-45309e136e463

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-261-0131722026101100 CAPSULE in 1 BOTTLE (31722-261-01) 100 capsule2023-05-11NoNoCurrent
31722-261-213172202612121 CAPSULE in 1 BOTTLE (31722-261-21) 21 capsule2023-05-11NoNoCurrent