FDA.reportPublic FDA data

Lenalidomide

Product NDC
70377-050
11-digit product format
703770050
Labeler code
70377
Product ID
70377-050_709e3342-23d5-10cd-3241-5ef6fdf924fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lenalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
BIOCON PHARMA INC.,
Application
ANDA215759
Marketing category
ANDA
Marketing start
2025-03-03
Substance
LENALIDOMIDE
Active strength
5 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
A215759-001LENALIDOMIDELENALIDOMIDE2.5MGCAPSULE / ORALAB2025-03-03
A215759-002LENALIDOMIDELENALIDOMIDE5MGCAPSULE / ORALAB2025-03-03
A215759-003LENALIDOMIDELENALIDOMIDE10MGCAPSULE / ORALAB2025-03-03
A215759-004LENALIDOMIDELENALIDOMIDE15MGCAPSULE / ORALAB2025-03-03
A215759-005LENALIDOMIDELENALIDOMIDE20MGCAPSULE / ORALAB2025-03-03
A215759-006LENALIDOMIDELENALIDOMIDE25MGCAPSULE / ORALAB2025-03-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215759-001AB
A215759-002AB
A215759-003AB
A215759-004AB
A215759-005AB
A215759-006AB

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 UTC2026-02A215759-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2025-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215759-002LENALIDOMIDE5MGCAPSULE / ORALAB2025-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215759-003LENALIDOMIDE10MGCAPSULE / ORALAB2025-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215759-004LENALIDOMIDE15MGCAPSULE / ORALAB2025-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215759-005LENALIDOMIDE20MGCAPSULE / ORALAB2025-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215759-006LENALIDOMIDE25MGCAPSULE / ORALAB2025-03-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215759-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2025-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215759-002LENALIDOMIDE5MGCAPSULE / ORALAB2025-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215759-003LENALIDOMIDE10MGCAPSULE / ORALAB2025-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215759-004LENALIDOMIDE15MGCAPSULE / ORALAB2025-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215759-005LENALIDOMIDE20MGCAPSULE / ORALAB2025-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215759-006LENALIDOMIDE25MGCAPSULE / ORALAB2025-03-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A215759-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2025-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215759-002LENALIDOMIDE5MGCAPSULE / ORALAB2025-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215759-003LENALIDOMIDE10MGCAPSULE / ORALAB2025-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215759-004LENALIDOMIDE15MGCAPSULE / ORALAB2025-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215759-005LENALIDOMIDE20MGCAPSULE / ORALAB2025-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215759-006LENALIDOMIDE25MGCAPSULE / ORALAB2025-03-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215759-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2025-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215759-002LENALIDOMIDE5MGCAPSULE / ORALAB2025-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215759-003LENALIDOMIDE10MGCAPSULE / ORALAB2025-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215759-004LENALIDOMIDE15MGCAPSULE / ORALAB2025-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215759-005LENALIDOMIDE20MGCAPSULE / ORALAB2025-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215759-006LENALIDOMIDE25MGCAPSULE / ORALAB2025-03-03fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215759-001LENALIDOMIDE2.5MGCAPSULE / ORALAB2025-03-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215759-002LENALIDOMIDE5MGCAPSULE / ORALAB2025-03-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215759-003LENALIDOMIDE10MGCAPSULE / ORALAB2025-03-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215759-004LENALIDOMIDE15MGCAPSULE / ORALAB2025-03-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215759-005LENALIDOMIDE20MGCAPSULE / ORALAB2025-03-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215759-006LENALIDOMIDE25MGCAPSULE / ORALAB2025-03-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215759-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215759-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215759-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215759-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215759-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215759-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215759-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215759-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215759-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215759-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215759-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215759-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215759-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215759-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215759-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215759-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215759-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215759-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215759-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215759-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215759-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215759-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215759-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215759-006AB1fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215759-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215759-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215759-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215759-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215759-005AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215759-006AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Lenalidomide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LENALIDOMIDE5 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
ed7a3099-ce31-4865-b212-358d9ff6261bAvailable 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
70377-050-12Lenalidomide100 in 1 BOTTLECAPSULE1009
70377-050-13Lenalidomide28 in 1 BOTTLECAPSULE289

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70377-050-13EA - Each70377-0500793123d-4e66-4a2e-a903-a2c1abe48f5312025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70377-050LENALIDOMIDE CAPSULE [BIOCON PHARMA INC.,]9Current NDC, 2 package rows20250306_ed7a3099-ce31-4865-b212-358d9ff6261b.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
LenalidomideLENALIDOMIDEBIOCON PHARMA INC.,ed7a3099-ce31-4865-b212-358d9ff6261b2025-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215759
application number: ANDA215759
ndc (product): 70377-050

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602910lenalidomide 10 MG Oral CapsulePSNed7a3099-ce31-4865-b212-358d9ff6261b9
643712lenalidomide 15 MG Oral CapsulePSNed7a3099-ce31-4865-b212-358d9ff6261b9
1242231lenalidomide 2.5 MG Oral CapsulePSNed7a3099-ce31-4865-b212-358d9ff6261b9
1428947lenalidomide 20 MG Oral CapsulePSNed7a3099-ce31-4865-b212-358d9ff6261b9
643720lenalidomide 25 MG Oral CapsulePSNed7a3099-ce31-4865-b212-358d9ff6261b9
602912lenalidomide 5 MG Oral CapsulePSNed7a3099-ce31-4865-b212-358d9ff6261b9
602910lenalidomide 10 MG Oral CapsuleSCDed7a3099-ce31-4865-b212-358d9ff6261b9
643712lenalidomide 15 MG Oral CapsuleSCDed7a3099-ce31-4865-b212-358d9ff6261b9
1242231lenalidomide 2.5 MG Oral CapsuleSCDed7a3099-ce31-4865-b212-358d9ff6261b9
1428947lenalidomide 20 MG Oral CapsuleSCDed7a3099-ce31-4865-b212-358d9ff6261b9
643720lenalidomide 25 MG Oral CapsuleSCDed7a3099-ce31-4865-b212-358d9ff6261b9
602912lenalidomide 5 MG Oral CapsuleSCDed7a3099-ce31-4865-b212-358d9ff6261b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70377-050-1270377005012100 CAPSULE in 1 BOTTLE (70377-050-12) 100 capsule2025-03-03NoNoCurrent
70377-050-137037700501328 CAPSULE in 1 BOTTLE (70377-050-13) 28 capsule2025-03-03NoNoCurrent