Home DailyMed fd23328f-b019-4c14-80d9-4ebd997f26b2 LENALIDOMIDE capsules, for oral use Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
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# Product LENALIDOMIDE
Active ingredient LENALIDOMIDE
Label structure 1 sections
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY SPL version 602910 lenalidomide 10 MG Oral Capsule PSN 5 643712 lenalidomide 15 MG Oral Capsule PSN 5 1242231 lenalidomide 2.5 MG Oral Capsule PSN 5 1428947 lenalidomide 20 MG Oral Capsule PSN 5 643720 lenalidomide 25 MG Oral Capsule PSN 5 602912 lenalidomide 5 MG Oral Capsule PSN 5 602910 lenalidomide 10 MG Oral Capsule SCD 5 643712 lenalidomide 15 MG Oral Capsule SCD 5 1242231 lenalidomide 2.5 MG Oral Capsule SCD 5 1428947 lenalidomide 20 MG Oral Capsule SCD 5 643720 lenalidomide 25 MG Oral Capsule SCD 5 602912 lenalidomide 5 MG Oral Capsule SCD 5
DailyMed Pharmacologic Classes# DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1676 LENALIDOMIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED] 5 Current NDC, 2 package rows 20241204_fd23328f-b019-4c14-80d9-4ebd997f26b2.zip 70771-1677 LENALIDOMIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED] 5 Current NDC, Legacy NDC, 2 package rows 20241204_fd23328f-b019-4c14-80d9-4ebd997f26b2.zip 70771-1678 LENALIDOMIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED] 5 Current NDC, Legacy NDC, 2 package rows 20241204_fd23328f-b019-4c14-80d9-4ebd997f26b2.zip 70771-1679 LENALIDOMIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED] 5 Current NDC, Legacy NDC, 2 package rows 20241204_fd23328f-b019-4c14-80d9-4ebd997f26b2.zip 70771-1680 LENALIDOMIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED] 5 Current NDC, 2 package rows 20241204_fd23328f-b019-4c14-80d9-4ebd997f26b2.zip 70771-1681 LENALIDOMIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED] 5 Current NDC, Legacy NDC, 2 package rows 20241204_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.
LENALIDOMIDE ANHYDROUS LACTOSE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FERROSOFERRIC OXIDE GELATIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE POTASSIUM HYDROXIDE SHELLAC TITANIUM DIOXIDE D&C RED NO. 33 D&C YELLOW NO. 10 FD&C BLUE NO. 1 D&C RED NO. 28 FD&C RED NO. 40 FD&C YELLOW NO. 6 Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 2 · 80 matching rows.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210154-001 LENALIDOMIDE LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-09-12 A210154-002 LENALIDOMIDE LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-09-12 A210154-003 LENALIDOMIDE LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-09-12 A210154-004 LENALIDOMIDE LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-09-12 A210154-005 LENALIDOMIDE LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 A210154-006 LENALIDOMIDE LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A210154-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-09-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210154-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-09-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210154-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-09-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210154-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-09-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210154-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210154-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210154-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-09-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210154-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-09-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210154-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-09-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210154-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-09-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210154-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210154-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210154-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210154-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210154-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210154-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210154-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210154-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210154-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-09-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210154-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-09-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210154-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-09-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210154-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-09-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210154-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210154-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210154-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-09-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210154-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-09-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210154-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-09-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210154-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-09-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210154-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210154-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210154-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-09-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210154-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-09-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210154-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-09-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210154-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-09-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210154-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210154-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210154-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-09-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210154-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-09-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210154-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-09-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210154-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-09-12 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 162 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.