Lenalidomide

Product NDC
63304-046
11-digit product format
633040046
Labeler code
63304
Product ID
63304-046_2922537e-47de-b6b9-e063-6294a90a0f19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lenalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA211846
Marketing category
ANDA
Marketing start
2023-03-04
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 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
A211846-001LENALIDOMIDELENALIDOMIDE5MGCAPSULE / ORALAB2023-02-08
A211846-002LENALIDOMIDELENALIDOMIDE10MGCAPSULE / ORALAB2023-02-08
A211846-003LENALIDOMIDELENALIDOMIDE15MGCAPSULE / ORALAB2023-02-08
A211846-004LENALIDOMIDELENALIDOMIDE25MGCAPSULE / ORALAB2023-02-08
A211846-005LENALIDOMIDELENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-06
A211846-006LENALIDOMIDELENALIDOMIDE20MGCAPSULE / 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
A211846-001AB
A211846-002AB
A211846-003AB
A211846-004AB
A211846-005AB
A211846-006AB

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 · 138 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211846-001LENALIDOMIDE5MGCAPSULE / ORALAB2023-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211846-002LENALIDOMIDE10MGCAPSULE / ORALAB2023-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211846-003LENALIDOMIDE15MGCAPSULE / ORALAB2023-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211846-004LENALIDOMIDE25MGCAPSULE / ORALAB2023-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211846-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211846-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211846-001LENALIDOMIDE5MGCAPSULE / ORALAB2023-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211846-002LENALIDOMIDE10MGCAPSULE / ORALAB2023-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211846-003LENALIDOMIDE15MGCAPSULE / ORALAB2023-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211846-004LENALIDOMIDE25MGCAPSULE / ORALAB2023-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211846-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211846-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A211846-001LENALIDOMIDE5MGCAPSULE / ORALAB2023-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211846-002LENALIDOMIDE10MGCAPSULE / ORALAB2023-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211846-003LENALIDOMIDE15MGCAPSULE / ORALAB2023-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211846-004LENALIDOMIDE25MGCAPSULE / ORALAB2023-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211846-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211846-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211846-001LENALIDOMIDE5MGCAPSULE / ORALAB2023-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211846-002LENALIDOMIDE10MGCAPSULE / ORALAB2023-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211846-003LENALIDOMIDE15MGCAPSULE / ORALAB2023-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211846-004LENALIDOMIDE25MGCAPSULE / ORALAB2023-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211846-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211846-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211846-001LENALIDOMIDE5MGCAPSULE / ORALAB2023-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211846-002LENALIDOMIDE10MGCAPSULE / ORALAB2023-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211846-003LENALIDOMIDE15MGCAPSULE / ORALAB2023-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211846-004LENALIDOMIDE25MGCAPSULE / ORALAB2023-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211846-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211846-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211846-001LENALIDOMIDE5MGCAPSULE / ORALAB2023-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211846-002LENALIDOMIDE10MGCAPSULE / ORALAB2023-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211846-003LENALIDOMIDE15MGCAPSULE / ORALAB2023-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211846-004LENALIDOMIDE25MGCAPSULE / ORALAB2023-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211846-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211846-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211846-001LENALIDOMIDE5MGCAPSULE / ORALAB2023-02-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211846-002LENALIDOMIDE10MGCAPSULE / ORALAB2023-02-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211846-003LENALIDOMIDE15MGCAPSULE / ORALAB2023-02-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211846-004LENALIDOMIDE25MGCAPSULE / ORALAB2023-02-082680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 138 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211846-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211846-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211846-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211846-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211846-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211846-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211846-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211846-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211846-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211846-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211846-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211846-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211846-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211846-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211846-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211846-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211846-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211846-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211846-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211846-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211846-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211846-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211846-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211846-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211846-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211846-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211846-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211846-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211846-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211846-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211846-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211846-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211846-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211846-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211846-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211846-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211846-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211846-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211846-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211846-004AB12680178bc6a6…

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
84d9dec7-9250-4dbd-9a0d-23e75f111892Available 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
63304-046-01Lenalidomide100 in 1 BOTTLECAPSULE1006
63304-046-22Lenalidomide21 in 1 BOTTLECAPSULE216

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-046-22EA - Each63304-0467ee812f8-6696-4972-b8c5-5ac464df1de712023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-046LENALIDOMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Current NDC, 2 package rows20241215_84d9dec7-9250-4dbd-9a0d-23e75f111892.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
LenalidomideLENALIDOMIDESun Pharmaceutical Industries, Inc.84d9dec7-9250-4dbd-9a0d-23e75f1118922024-12-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211846
application number: ANDA211846
ndc (product): 63304-046

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602910lenalidomide 10 MG Oral CapsulePSN84d9dec7-9250-4dbd-9a0d-23e75f1118926
643712lenalidomide 15 MG Oral CapsulePSN84d9dec7-9250-4dbd-9a0d-23e75f1118926
1242231lenalidomide 2.5 MG Oral CapsulePSN84d9dec7-9250-4dbd-9a0d-23e75f1118926
1428947lenalidomide 20 MG Oral CapsulePSN84d9dec7-9250-4dbd-9a0d-23e75f1118926
643720lenalidomide 25 MG Oral CapsulePSN84d9dec7-9250-4dbd-9a0d-23e75f1118926
602912lenalidomide 5 MG Oral CapsulePSN84d9dec7-9250-4dbd-9a0d-23e75f1118926
602910lenalidomide 10 MG Oral CapsuleSCD84d9dec7-9250-4dbd-9a0d-23e75f1118926
643712lenalidomide 15 MG Oral CapsuleSCD84d9dec7-9250-4dbd-9a0d-23e75f1118926
1242231lenalidomide 2.5 MG Oral CapsuleSCD84d9dec7-9250-4dbd-9a0d-23e75f1118926
1428947lenalidomide 20 MG Oral CapsuleSCD84d9dec7-9250-4dbd-9a0d-23e75f1118926
643720lenalidomide 25 MG Oral CapsuleSCD84d9dec7-9250-4dbd-9a0d-23e75f1118926
602912lenalidomide 5 MG Oral CapsuleSCD84d9dec7-9250-4dbd-9a0d-23e75f1118926

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63304-046-0163304004601100 CAPSULE in 1 BOTTLE (63304-046-01) 100 capsule2023-03-04NoNoCurrent
63304-046-226330400462221 CAPSULE in 1 BOTTLE (63304-046-22) 21 capsule2023-03-04NoNoCurrent