LENALIDOMIDE capsules, for oral use

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-11-30
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 21:18:38

Label at a glance#

ProductLENALIDOMIDE
Active ingredientLENALIDOMIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1676-7

Lenalidomide Capsules, 2.5 mg

28 Capsules

Rx only

2.5 mg label
2.5 mg label

NDC 70771-1677-7

Lenalidomide Capsules, 5 mg

28 Capsules

Rx only

5 mg label
5 mg label

NDC 70771-1678-7

Lenalidomide Capsules, 10 mg

28 Capsules

Rx only

10 mg label
10 mg label

NDC 70771-1679-8

Lenalidomide Capsules, 15 mg

21 Capsules

Rx only

15 mg label
15 mg label

NDC 70771-1680-8

Lenalidomide Capsules, 20 mg

21 Capsules

Rx only

20 mg label
20 mg label

NDC 70771-1681-8

Lenalidomide Capsules, 25 mg

21 Capsules

Rx only

25 mg label
25 mg label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
602910lenalidomide 10 MG Oral CapsulePSN5
643712lenalidomide 15 MG Oral CapsulePSN5
1242231lenalidomide 2.5 MG Oral CapsulePSN5
1428947lenalidomide 20 MG Oral CapsulePSN5
643720lenalidomide 25 MG Oral CapsulePSN5
602912lenalidomide 5 MG Oral CapsulePSN5
602910lenalidomide 10 MG Oral CapsuleSCD5
643712lenalidomide 15 MG Oral CapsuleSCD5
1242231lenalidomide 2.5 MG Oral CapsuleSCD5
1428947lenalidomide 20 MG Oral CapsuleSCD5
643720lenalidomide 25 MG Oral CapsuleSCD5
602912lenalidomide 5 MG Oral CapsuleSCD5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LENALIDOMIDE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
70771-1676-1LENALIDOMIDE100 in 1 BOTTLECAPSULE1005
70771-1676-7LENALIDOMIDE28 in 1 BOTTLECAPSULE285
70771-1677-1LENALIDOMIDE100 in 1 BOTTLECAPSULE1005
70771-1677-7LENALIDOMIDE28 in 1 BOTTLECAPSULE285
70771-1678-1LENALIDOMIDE100 in 1 BOTTLECAPSULE1005
70771-1678-7LENALIDOMIDE28 in 1 BOTTLECAPSULE285
70771-1679-1LENALIDOMIDE100 in 1 BOTTLECAPSULE1005
70771-1679-8LENALIDOMIDE21 in 1 BOTTLECAPSULE215
70771-1680-1LENALIDOMIDE100 in 1 BOTTLECAPSULE1005
70771-1680-8LENALIDOMIDE21 in 1 BOTTLECAPSULE215
70771-1681-1LENALIDOMIDE100 in 1 BOTTLECAPSULE1005
70771-1681-8LENALIDOMIDE21 in 1 BOTTLECAPSULE215

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1676LENALIDOMIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED]5Current NDC, 2 package rows20241204_fd23328f-b019-4c14-80d9-4ebd997f26b2.zip
70771-1677LENALIDOMIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 2 package rows20241204_fd23328f-b019-4c14-80d9-4ebd997f26b2.zip
70771-1678LENALIDOMIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 2 package rows20241204_fd23328f-b019-4c14-80d9-4ebd997f26b2.zip
70771-1679LENALIDOMIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 2 package rows20241204_fd23328f-b019-4c14-80d9-4ebd997f26b2.zip
70771-1680LENALIDOMIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED]5Current NDC, 2 package rows20241204_fd23328f-b019-4c14-80d9-4ebd997f26b2.zip
70771-1681LENALIDOMIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 2 package rows20241204_fd23328f-b019-4c14-80d9-4ebd997f26b2.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 80 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A210154-001LENALIDOMIDELENALIDOMIDE5MGCAPSULE / ORALAB2022-09-12
A210154-002LENALIDOMIDELENALIDOMIDE10MGCAPSULE / ORALAB2022-09-12
A210154-003LENALIDOMIDELENALIDOMIDE15MGCAPSULE / ORALAB2022-09-12
A210154-004LENALIDOMIDELENALIDOMIDE25MGCAPSULE / ORALAB2022-09-12
A210154-005LENALIDOMIDELENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-06
A210154-006LENALIDOMIDELENALIDOMIDE20MGCAPSULE / 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
A210154-001AB
A210154-002AB
A210154-003AB
A210154-004AB
A210154-005AB
A210154-006AB

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 5 · 162 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210154-001LENALIDOMIDE5MGCAPSULE / ORALAB2022-09-1284e616aacf4f…
2026-09-14 22:38:342026-08A210154-002LENALIDOMIDE10MGCAPSULE / ORALAB2022-09-1284e616aacf4f…
2026-09-14 22:38:342026-08A210154-003LENALIDOMIDE15MGCAPSULE / ORALAB2022-09-1284e616aacf4f…
2026-09-14 22:38:342026-08A210154-004LENALIDOMIDE25MGCAPSULE / ORALAB2022-09-1284e616aacf4f…
2026-09-14 22:38:342026-08A210154-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-0684e616aacf4f…
2026-09-14 22:38:342026-08A210154-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-0684e616aacf4f…
2026-08-18 06:07:402026-07A210154-001LENALIDOMIDE5MGCAPSULE / ORALAB2022-09-12caaa826d4ba7…
2026-08-18 06:07:402026-07A210154-002LENALIDOMIDE10MGCAPSULE / ORALAB2022-09-12caaa826d4ba7…
2026-08-18 06:07:402026-07A210154-003LENALIDOMIDE15MGCAPSULE / ORALAB2022-09-12caaa826d4ba7…
2026-08-18 06:07:402026-07A210154-004LENALIDOMIDE25MGCAPSULE / ORALAB2022-09-12caaa826d4ba7…
2026-08-18 06:07:402026-07A210154-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-06caaa826d4ba7…
2026-08-18 06:07:402026-07A210154-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210154-001LENALIDOMIDE5MGCAPSULE / ORALAB2022-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210154-002LENALIDOMIDE10MGCAPSULE / ORALAB2022-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210154-003LENALIDOMIDE15MGCAPSULE / ORALAB2022-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210154-004LENALIDOMIDE25MGCAPSULE / ORALAB2022-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210154-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210154-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210154-001LENALIDOMIDE5MGCAPSULE / ORALAB2022-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210154-002LENALIDOMIDE10MGCAPSULE / ORALAB2022-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210154-003LENALIDOMIDE15MGCAPSULE / ORALAB2022-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210154-004LENALIDOMIDE25MGCAPSULE / ORALAB2022-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210154-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210154-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A210154-001LENALIDOMIDE5MGCAPSULE / ORALAB2022-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210154-002LENALIDOMIDE10MGCAPSULE / ORALAB2022-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210154-003LENALIDOMIDE15MGCAPSULE / ORALAB2022-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210154-004LENALIDOMIDE25MGCAPSULE / ORALAB2022-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210154-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210154-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210154-001LENALIDOMIDE5MGCAPSULE / ORALAB2022-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210154-002LENALIDOMIDE10MGCAPSULE / ORALAB2022-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210154-003LENALIDOMIDE15MGCAPSULE / ORALAB2022-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210154-004LENALIDOMIDE25MGCAPSULE / ORALAB2022-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210154-005LENALIDOMIDE2.5MGCAPSULE / ORALAB2023-03-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210154-006LENALIDOMIDE20MGCAPSULE / ORALAB2023-03-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210154-001LENALIDOMIDE5MGCAPSULE / ORALAB2022-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210154-002LENALIDOMIDE10MGCAPSULE / ORALAB2022-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210154-003LENALIDOMIDE15MGCAPSULE / ORALAB2022-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210154-004LENALIDOMIDE25MGCAPSULE / ORALAB2022-09-12b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 162 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A210154-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A210154-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A210154-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A210154-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A210154-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A210154-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A210154-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210154-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210154-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210154-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210154-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210154-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210154-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210154-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210154-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210154-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210154-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210154-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210154-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210154-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210154-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210154-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210154-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210154-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210154-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210154-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210154-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210154-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210154-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210154-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210154-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210154-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210154-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210154-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210154-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210154-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210154-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210154-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210154-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210154-004AB1b8a1b40f171c…

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
LENALIDOMIDELENALIDOMIDEZydus Lifesciences Limitedfd23328f-b019-4c14-80d9-4ebd997f26b22024-11-30Exact identifier
ndc (package): 70771-1676-7
ndc (package): 70771-1678-7
ndc (package): 70771-1677-7
ndc (package): 70771-1681-1
ndc (package): 70771-1679-1
ndc (package): 70771-1677-1
ndc (package): 70771-1678-1
ndc (package): 70771-1679-8
ndc (package): 70771-1680-8
ndc (package): 70771-1680-1
ndc (package): 70771-1681-8
ndc (package): 70771-1676-1
ndc (product): 70771-1680
ndc (product): 70771-1677
ndc (product): 70771-1681
ndc (product): 70771-1679
ndc (product): 70771-1676
ndc (product): 70771-1678
ndc11 (package): 70771168001
ndc11 (package): 70771167807
ndc11 (package): 70771167601
ndc11 (package): 70771167607
ndc11 (package): 70771167901
ndc11 (package): 70771167908
ndc11 (package): 70771168101
ndc11 (package): 70771167701
ndc11 (package): 70771168108
ndc11 (package): 70771167801
ndc11 (package): 70771167707
ndc11 (package): 70771168008
spl id: b85844ee-03a3-407f-97a9-ae0098212923
spl set id: fd23328f-b019-4c14-80d9-4ebd997f26b2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.