Lenalidomide

Product NDC
0378-1940
11-digit product format
003781940
Labeler code
0378
Product ID
0378-1940_3d041421-9aaf-4f7a-b5e2-b75899dc03c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lenalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA213912
Marketing category
ANDA
Marketing start
2022-09-06
Substance
LENALIDOMIDE
Active strength
25 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 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
A213912-001LENALIDOMIDELENALIDOMIDE5MGCAPSULE / ORALAB2022-08-30
A213912-002LENALIDOMIDELENALIDOMIDE10MGCAPSULE / ORALAB2022-08-30
A213912-003LENALIDOMIDELENALIDOMIDE15MGCAPSULE / ORALAB2022-08-30
A213912-004LENALIDOMIDELENALIDOMIDE25MGCAPSULE / ORALAB2022-08-30
A213912-005LENALIDOMIDELENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-06
A213912-006LENALIDOMIDELENALIDOMIDE20MGCAPSULE / ORALAB2023-03-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213912-001AB
A213912-002AB
A213912-003AB
A213912-004AB
A213912-005AB
A213912-006AB

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 · 154 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213912-001LENALIDOMIDE5MGCAPSULE / ORALAB2022-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213912-002LENALIDOMIDE10MGCAPSULE / ORALAB2022-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213912-003LENALIDOMIDE15MGCAPSULE / ORALAB2022-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213912-004LENALIDOMIDE25MGCAPSULE / ORALAB2022-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213912-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213912-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213912-001LENALIDOMIDE5MGCAPSULE / ORALAB2022-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213912-002LENALIDOMIDE10MGCAPSULE / ORALAB2022-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213912-003LENALIDOMIDE15MGCAPSULE / ORALAB2022-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213912-004LENALIDOMIDE25MGCAPSULE / ORALAB2022-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213912-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213912-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A213912-001LENALIDOMIDE5MGCAPSULE / ORALAB2022-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213912-002LENALIDOMIDE10MGCAPSULE / ORALAB2022-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213912-003LENALIDOMIDE15MGCAPSULE / ORALAB2022-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213912-004LENALIDOMIDE25MGCAPSULE / ORALAB2022-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213912-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213912-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213912-001LENALIDOMIDE5MGCAPSULE / ORALAB2022-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213912-002LENALIDOMIDE10MGCAPSULE / ORALAB2022-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213912-003LENALIDOMIDE15MGCAPSULE / ORALAB2022-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213912-004LENALIDOMIDE25MGCAPSULE / ORALAB2022-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213912-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213912-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213912-001LENALIDOMIDE5MGCAPSULE / ORALAB2022-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213912-002LENALIDOMIDE10MGCAPSULE / ORALAB2022-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213912-003LENALIDOMIDE15MGCAPSULE / ORALAB2022-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213912-004LENALIDOMIDE25MGCAPSULE / ORALAB2022-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213912-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213912-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213912-001LENALIDOMIDE5MGCAPSULE / ORALAB2022-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213912-002LENALIDOMIDE10MGCAPSULE / ORALAB2022-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213912-003LENALIDOMIDE15MGCAPSULE / ORALAB2022-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213912-004LENALIDOMIDE25MGCAPSULE / ORALAB2022-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213912-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213912-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213912-001LENALIDOMIDE5MGCAPSULE / ORALAB2022-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213912-002LENALIDOMIDE10MGCAPSULE / ORALAB2022-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213912-003LENALIDOMIDE15MGCAPSULE / ORALAB2022-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213912-004LENALIDOMIDE25MGCAPSULE / ORALAB2022-08-302680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 154 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213912-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213912-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213912-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213912-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213912-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213912-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213912-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213912-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213912-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213912-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213912-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213912-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213912-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213912-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213912-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213912-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213912-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213912-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213912-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213912-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213912-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213912-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213912-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213912-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213912-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213912-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213912-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213912-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213912-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213912-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213912-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213912-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213912-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213912-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213912-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213912-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213912-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213912-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213912-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213912-004AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Lenalidomide
Listing expiration
2027-12-31

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
76f6c1e7-985b-43d9-892c-849df50ae80eAvailable 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
0378-1940-01Lenalidomide100 in 1 BOTTLE, PLASTICCAPSULE1004
0378-1940-21Lenalidomide21 in 1 BOTTLE, PLASTICCAPSULE214

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1940-01EA - Each0378-1940ef586898-606b-4cde-9fc1-a66e7f9c398012022-10-06
0378-1940-21EA - Each0378-1940279adbf8-f85c-4126-9cef-2e51b334ff4a12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-1940LENALIDOMIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20231114_76f6c1e7-985b-43d9-892c-849df50ae80e.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
LenalidomideLENALIDOMIDEMylan Pharmaceuticals Inc.76f6c1e7-985b-43d9-892c-849df50ae80e2023-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213912
application number: ANDA213912
ndc (product): 0378-1940

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602910lenalidomide 10 MG Oral CapsulePSN76f6c1e7-985b-43d9-892c-849df50ae80e4
643712lenalidomide 15 MG Oral CapsulePSN76f6c1e7-985b-43d9-892c-849df50ae80e4
1242231lenalidomide 2.5 MG Oral CapsulePSN76f6c1e7-985b-43d9-892c-849df50ae80e4
1428947lenalidomide 20 MG Oral CapsulePSN76f6c1e7-985b-43d9-892c-849df50ae80e4
643720lenalidomide 25 MG Oral CapsulePSN76f6c1e7-985b-43d9-892c-849df50ae80e4
602912lenalidomide 5 MG Oral CapsulePSN76f6c1e7-985b-43d9-892c-849df50ae80e4
602910lenalidomide 10 MG Oral CapsuleSCD76f6c1e7-985b-43d9-892c-849df50ae80e4
643712lenalidomide 15 MG Oral CapsuleSCD76f6c1e7-985b-43d9-892c-849df50ae80e4
1242231lenalidomide 2.5 MG Oral CapsuleSCD76f6c1e7-985b-43d9-892c-849df50ae80e4
1428947lenalidomide 20 MG Oral CapsuleSCD76f6c1e7-985b-43d9-892c-849df50ae80e4
643720lenalidomide 25 MG Oral CapsuleSCD76f6c1e7-985b-43d9-892c-849df50ae80e4
602912lenalidomide 5 MG Oral CapsuleSCD76f6c1e7-985b-43d9-892c-849df50ae80e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-1940-0100378194001100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01) 100 capsule2022-09-060000-00-00NoNoCurrent
0378-1940-210037819402121 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21) 21 capsule2022-09-060000-00-00NoNoCurrent