LENALIDOMIDE

Product NDC
60219-1716
11-digit product format
602191716
Labeler code
60219
Product ID
60219-1716_85e664d1-1d56-4b9b-b2a1-96b32b5b1a7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lenalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA216213
Marketing category
ANDA
Marketing start
2025-02-12
Substance
LENALIDOMIDE
Active strength
10 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
A216213-001LENALIDOMIDELENALIDOMIDE2.5MGCAPSULE / ORALAB2025-01-31
A216213-002LENALIDOMIDELENALIDOMIDE5MGCAPSULE / ORALAB2025-01-31
A216213-003LENALIDOMIDELENALIDOMIDE10MGCAPSULE / ORALAB2025-01-31
A216213-004LENALIDOMIDELENALIDOMIDE15MGCAPSULE / ORALAB2025-01-31
A216213-005LENALIDOMIDELENALIDOMIDE20MGCAPSULE / ORALAB2025-01-31
A216213-006LENALIDOMIDELENALIDOMIDE25MGCAPSULE / ORALAB2025-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216213-001AB
A216213-002AB
A216213-003AB
A216213-004AB
A216213-005AB
A216213-006AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216213-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2025-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216213-002LENALIDOMIDE5MGCAPSULE / ORALAB2025-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216213-003LENALIDOMIDE10MGCAPSULE / ORALAB2025-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216213-004LENALIDOMIDE15MGCAPSULE / ORALAB2025-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216213-005LENALIDOMIDE20MGCAPSULE / ORALAB2025-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216213-006LENALIDOMIDE25MGCAPSULE / ORALAB2025-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216213-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2025-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216213-002LENALIDOMIDE5MGCAPSULE / ORALAB2025-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216213-003LENALIDOMIDE10MGCAPSULE / ORALAB2025-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216213-004LENALIDOMIDE15MGCAPSULE / ORALAB2025-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216213-005LENALIDOMIDE20MGCAPSULE / ORALAB2025-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216213-006LENALIDOMIDE25MGCAPSULE / ORALAB2025-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216213-001LENALIDOMIDE2.5MGCAPSULE / ORAL2025-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216213-002LENALIDOMIDE5MGCAPSULE / ORAL2025-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216213-003LENALIDOMIDE10MGCAPSULE / ORAL2025-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216213-004LENALIDOMIDE15MGCAPSULE / ORAL2025-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216213-005LENALIDOMIDE20MGCAPSULE / ORAL2025-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216213-006LENALIDOMIDE25MGCAPSULE / ORAL2025-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216213-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2025-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216213-002LENALIDOMIDE5MGCAPSULE / ORALAB2025-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216213-003LENALIDOMIDE10MGCAPSULE / ORALAB2025-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216213-004LENALIDOMIDE15MGCAPSULE / ORALAB2025-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216213-005LENALIDOMIDE20MGCAPSULE / ORALAB2025-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216213-006LENALIDOMIDE25MGCAPSULE / ORALAB2025-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216213-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2025-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216213-002LENALIDOMIDE5MGCAPSULE / ORALAB2025-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216213-003LENALIDOMIDE10MGCAPSULE / ORALAB2025-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216213-004LENALIDOMIDE15MGCAPSULE / ORALAB2025-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216213-005LENALIDOMIDE20MGCAPSULE / ORALAB2025-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216213-006LENALIDOMIDE25MGCAPSULE / ORALAB2025-01-31b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216213-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2025-01-31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216213-002LENALIDOMIDE5MGCAPSULE / ORALAB2025-01-31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216213-003LENALIDOMIDE10MGCAPSULE / ORALAB2025-01-31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216213-004LENALIDOMIDE15MGCAPSULE / ORALAB2025-01-31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216213-005LENALIDOMIDE20MGCAPSULE / ORALAB2025-01-31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216213-006LENALIDOMIDE25MGCAPSULE / ORALAB2025-01-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216213-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216213-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216213-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216213-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216213-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216213-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216213-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216213-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216213-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216213-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216213-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216213-006AB131067a03dcf5…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216213-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216213-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216213-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216213-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216213-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216213-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216213-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216213-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216213-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216213-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216213-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216213-006AB1b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216213-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216213-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216213-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216213-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216213-005AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216213-006AB1a50c72e98297…

Additional Listing Data#

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

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
da7b5dda-79ed-4c4a-88aa-52394fdc7c54Available 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
60219-1716-1LENALIDOMIDE28 in 1 BOTTLECAPSULE286
60219-1716-2LENALIDOMIDE100 in 1 BOTTLECAPSULE1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-1716-1EA - Each60219-1716e2c2d823-abfc-42fa-8ae8-b0981f86a6e212026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-1716LENALIDOMIDE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]5Current NDC, 2 package rows20250214_da7b5dda-79ed-4c4a-88aa-52394fdc7c54.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
LENALIDOMIDELENALIDOMIDEAmneal Pharmaceuticals NY LLCda7b5dda-79ed-4c4a-88aa-52394fdc7c542026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216213
application number: ANDA216213
ndc (product): 60219-1716

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602910lenalidomide 10 MG Oral CapsulePSNda7b5dda-79ed-4c4a-88aa-52394fdc7c546
643712lenalidomide 15 MG Oral CapsulePSNda7b5dda-79ed-4c4a-88aa-52394fdc7c546
1242231lenalidomide 2.5 MG Oral CapsulePSNda7b5dda-79ed-4c4a-88aa-52394fdc7c546
1428947lenalidomide 20 MG Oral CapsulePSNda7b5dda-79ed-4c4a-88aa-52394fdc7c546
643720lenalidomide 25 MG Oral CapsulePSNda7b5dda-79ed-4c4a-88aa-52394fdc7c546
602912lenalidomide 5 MG Oral CapsulePSNda7b5dda-79ed-4c4a-88aa-52394fdc7c546
602910lenalidomide 10 MG Oral CapsuleSCDda7b5dda-79ed-4c4a-88aa-52394fdc7c546
643712lenalidomide 15 MG Oral CapsuleSCDda7b5dda-79ed-4c4a-88aa-52394fdc7c546
1242231lenalidomide 2.5 MG Oral CapsuleSCDda7b5dda-79ed-4c4a-88aa-52394fdc7c546
1428947lenalidomide 20 MG Oral CapsuleSCDda7b5dda-79ed-4c4a-88aa-52394fdc7c546
643720lenalidomide 25 MG Oral CapsuleSCDda7b5dda-79ed-4c4a-88aa-52394fdc7c546
602912lenalidomide 5 MG Oral CapsuleSCDda7b5dda-79ed-4c4a-88aa-52394fdc7c546

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60219-1716-16021917160128 CAPSULE in 1 BOTTLE (60219-1716-1) 28 capsule2025-02-12NoNoCurrent
60219-1716-260219171602100 CAPSULE in 1 BOTTLE (60219-1716-2) 100 capsule2025-02-12NoNoCurrent