FDA.reportPublic FDA data

Lenalidomide

Product NDC
16729-697
Requested package NDC
16729-697-06
11-digit product format
167290697
Labeler code
16729
Product ID
16729-697_513e8d33-e9bf-df2b-e063-6394a90a1ee9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lenalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA218872
Marketing category
ANDA
Marketing start
2026-04-08
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
A218872-001LENALIDOMIDELENALIDOMIDE2.5MGCAPSULE / ORALAB2025-11-14
A218872-002LENALIDOMIDELENALIDOMIDE5MGCAPSULE / ORALAB2025-11-14
A218872-003LENALIDOMIDELENALIDOMIDE10MGCAPSULE / ORALAB2025-11-14
A218872-004LENALIDOMIDELENALIDOMIDE15MGCAPSULE / ORALAB2025-11-14
A218872-005LENALIDOMIDELENALIDOMIDE20MGCAPSULE / ORALAB2025-11-14
A218872-006LENALIDOMIDELENALIDOMIDE25MGCAPSULE / ORALAB2025-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218872-001AB
A218872-002AB
A218872-003AB
A218872-004AB
A218872-005AB
A218872-006AB

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
2026-08-01 22:54:322026-06A218872-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2025-11-14a50c72e98297…
2026-08-01 22:54:322026-06A218872-002LENALIDOMIDE5MGCAPSULE / ORALAB2025-11-14a50c72e98297…
2026-08-01 22:54:322026-06A218872-003LENALIDOMIDE10MGCAPSULE / ORALAB2025-11-14a50c72e98297…
2026-08-01 22:54:322026-06A218872-004LENALIDOMIDE15MGCAPSULE / ORALAB2025-11-14a50c72e98297…
2026-08-01 22:54:322026-06A218872-005LENALIDOMIDE20MGCAPSULE / ORALAB2025-11-14a50c72e98297…
2026-08-01 22:54:322026-06A218872-006LENALIDOMIDE25MGCAPSULE / ORALAB2025-11-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A218872-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A218872-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A218872-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A218872-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A218872-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A218872-006AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LenalidomideLENALIDOMIDEAccord Healthcare Inc.9c414531-a3bf-455a-aca7-9e716f42099a2026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218872
application number: ANDA218872
ndc (package): 16729-697-06
ndc (product): 16729-697
ndc11 (package): 16729069706

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
9c414531-a3bf-455a-aca7-9e716f42099aAvailable 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
16729-697-06Lenalidomide21 in 1 BOTTLECAPSULE216

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-697-06EA - Each16729-69729f87777-aff2-4b00-b9af-1506f578d58012026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602910lenalidomide 10 MG Oral CapsulePSN9c414531-a3bf-455a-aca7-9e716f42099a6
643712lenalidomide 15 MG Oral CapsulePSN9c414531-a3bf-455a-aca7-9e716f42099a6
1242231lenalidomide 2.5 MG Oral CapsulePSN9c414531-a3bf-455a-aca7-9e716f42099a6
1428947lenalidomide 20 MG Oral CapsulePSN9c414531-a3bf-455a-aca7-9e716f42099a6
643720lenalidomide 25 MG Oral CapsulePSN9c414531-a3bf-455a-aca7-9e716f42099a6
602912lenalidomide 5 MG Oral CapsulePSN9c414531-a3bf-455a-aca7-9e716f42099a6
602910lenalidomide 10 MG Oral CapsuleSCD9c414531-a3bf-455a-aca7-9e716f42099a6
643712lenalidomide 15 MG Oral CapsuleSCD9c414531-a3bf-455a-aca7-9e716f42099a6
1242231lenalidomide 2.5 MG Oral CapsuleSCD9c414531-a3bf-455a-aca7-9e716f42099a6
1428947lenalidomide 20 MG Oral CapsuleSCD9c414531-a3bf-455a-aca7-9e716f42099a6
643720lenalidomide 25 MG Oral CapsuleSCD9c414531-a3bf-455a-aca7-9e716f42099a6
602912lenalidomide 5 MG Oral CapsuleSCD9c414531-a3bf-455a-aca7-9e716f42099a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16729-697-061672906970621 CAPSULE in 1 BOTTLE (16729-697-06) 21 capsule2026-04-08NoNoCurrent