LENALIDOMIDE

Product NDC
47781-485
11-digit product format
477810485
Labeler code
47781
Product ID
47781-485_1c3e5289-7ff0-54c1-9146-f7ec3f49aea2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lenalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Alvogen, Inc.
Application
ANDA210480
Marketing category
ANDA
Marketing start
2022-09-03
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
A210480-001LENALIDOMIDELENALIDOMIDE5MGCAPSULE / ORALAB2022-08-31
A210480-002LENALIDOMIDELENALIDOMIDE10MGCAPSULE / ORALAB2022-08-31
A210480-003LENALIDOMIDELENALIDOMIDE15MGCAPSULE / ORALAB2022-08-31
A210480-004LENALIDOMIDELENALIDOMIDE25MGCAPSULE / ORALAB2022-08-31
A210480-005LENALIDOMIDELENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-06
A210480-006LENALIDOMIDELENALIDOMIDE20MGCAPSULE / 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
A210480-001AB
A210480-002AB
A210480-003AB
A210480-004AB
A210480-005AB
A210480-006AB

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 UTC2026-02A210480-001LENALIDOMIDE5MGCAPSULE / ORALAB2022-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210480-002LENALIDOMIDE10MGCAPSULE / ORALAB2022-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210480-003LENALIDOMIDE15MGCAPSULE / ORALAB2022-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210480-004LENALIDOMIDE25MGCAPSULE / ORALAB2022-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210480-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210480-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210480-001LENALIDOMIDE5MGCAPSULE / ORALAB2022-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210480-002LENALIDOMIDE10MGCAPSULE / ORALAB2022-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210480-003LENALIDOMIDE15MGCAPSULE / ORALAB2022-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210480-004LENALIDOMIDE25MGCAPSULE / ORALAB2022-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210480-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210480-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A210480-001LENALIDOMIDE5MGCAPSULE / ORALAB2022-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210480-002LENALIDOMIDE10MGCAPSULE / ORALAB2022-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210480-003LENALIDOMIDE15MGCAPSULE / ORALAB2022-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210480-004LENALIDOMIDE25MGCAPSULE / ORALAB2022-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210480-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210480-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210480-001LENALIDOMIDE5MGCAPSULE / ORALAB2022-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210480-002LENALIDOMIDE10MGCAPSULE / ORALAB2022-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210480-003LENALIDOMIDE15MGCAPSULE / ORALAB2022-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210480-004LENALIDOMIDE25MGCAPSULE / ORALAB2022-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210480-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210480-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210480-001LENALIDOMIDE5MGCAPSULE / ORALAB2022-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210480-002LENALIDOMIDE10MGCAPSULE / ORALAB2022-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210480-003LENALIDOMIDE15MGCAPSULE / ORALAB2022-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210480-004LENALIDOMIDE25MGCAPSULE / ORALAB2022-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210480-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210480-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210480-001LENALIDOMIDE5MGCAPSULE / ORALAB2022-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210480-002LENALIDOMIDE10MGCAPSULE / ORALAB2022-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210480-003LENALIDOMIDE15MGCAPSULE / ORALAB2022-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210480-004LENALIDOMIDE25MGCAPSULE / ORALAB2022-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210480-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210480-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210480-001LENALIDOMIDE5MGCAPSULE / ORALAB2022-08-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210480-002LENALIDOMIDE10MGCAPSULE / ORALAB2022-08-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210480-003LENALIDOMIDE15MGCAPSULE / ORALAB2022-08-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210480-004LENALIDOMIDE25MGCAPSULE / ORALAB2022-08-312680178bc6a6…

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 UTC2026-02A210480-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210480-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210480-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210480-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210480-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210480-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210480-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210480-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210480-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210480-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210480-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210480-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210480-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210480-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210480-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210480-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210480-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210480-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210480-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210480-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210480-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210480-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210480-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210480-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210480-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210480-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210480-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210480-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210480-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210480-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210480-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210480-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210480-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210480-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210480-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210480-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210480-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210480-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210480-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210480-004AB12680178bc6a6…

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
adee5af1-c9ab-c0c7-e400-dea7d2a0d4beAvailable 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
47781-485-01LENALIDOMIDE100 in 1 BOTTLECAPSULE1004
47781-485-28LENALIDOMIDE28 in 1 BOTTLECAPSULE284

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-485-01EA - Each47781-485ea73f85a-12ee-43a4-b0bb-512f2b3c49ab12022-10-06
47781-485-28EA - Each47781-485e09a28b2-dd09-4d4a-808b-1ad2d26bc43f12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-485LENALIDOMIDE CAPSULE [ALVOGEN, INC.]3Current NDC, Legacy NDC, 2 package rows20240606_adee5af1-c9ab-c0c7-e400-dea7d2a0d4be.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
LENALIDOMIDELENALIDOMIDEAlvogen, Inc.adee5af1-c9ab-c0c7-e400-dea7d2a0d4be2025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210480
application number: ANDA210480
ndc (product): 47781-485

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602910lenalidomide 10 MG Oral CapsulePSNadee5af1-c9ab-c0c7-e400-dea7d2a0d4be4
643712lenalidomide 15 MG Oral CapsulePSNadee5af1-c9ab-c0c7-e400-dea7d2a0d4be4
1242231lenalidomide 2.5 MG Oral CapsulePSNadee5af1-c9ab-c0c7-e400-dea7d2a0d4be4
1428947lenalidomide 20 MG Oral CapsulePSNadee5af1-c9ab-c0c7-e400-dea7d2a0d4be4
643720lenalidomide 25 MG Oral CapsulePSNadee5af1-c9ab-c0c7-e400-dea7d2a0d4be4
602912lenalidomide 5 MG Oral CapsulePSNadee5af1-c9ab-c0c7-e400-dea7d2a0d4be4
602910lenalidomide 10 MG Oral CapsuleSCDadee5af1-c9ab-c0c7-e400-dea7d2a0d4be4
643712lenalidomide 15 MG Oral CapsuleSCDadee5af1-c9ab-c0c7-e400-dea7d2a0d4be4
1242231lenalidomide 2.5 MG Oral CapsuleSCDadee5af1-c9ab-c0c7-e400-dea7d2a0d4be4
1428947lenalidomide 20 MG Oral CapsuleSCDadee5af1-c9ab-c0c7-e400-dea7d2a0d4be4
643720lenalidomide 25 MG Oral CapsuleSCDadee5af1-c9ab-c0c7-e400-dea7d2a0d4be4
602912lenalidomide 5 MG Oral CapsuleSCDadee5af1-c9ab-c0c7-e400-dea7d2a0d4be4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47781-485-0147781048501100 CAPSULE in 1 BOTTLE (47781-485-01) 100 capsule2022-09-030000-00-00NoNoCurrent
47781-485-284778104852828 CAPSULE in 1 BOTTLE (47781-485-28) 28 capsule2022-09-030000-00-00NoNoCurrent