Home NDC 60505-4532-2 Lenalidomide
Product NDC 60505-4532
Requested package NDC 60505-4532-2
11-digit product format 605054532
Labeler code 60505
Product ID 60505-4532_04dd2c41-a453-afcc-a2a2-bde0a8fd7353
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lenalidomide
Dosage form CAPSULE
Route ORAL
Labeler Apotex Corp.
Application ANDA211022
Marketing category ANDA
Marketing start 2023-03-09
Substance LENALIDOMIDE
Active strength 2.5 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 44 .
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 A211022-001 LENALIDOMIDE LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-08-30 A211022-002 LENALIDOMIDE LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-08-30 A211022-003 LENALIDOMIDE LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-08-30 A211022-004 LENALIDOMIDE LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-08-30 A211022-005 LENALIDOMIDE LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-07 A211022-006 LENALIDOMIDE LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-07
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 · 172 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 2026-10-15 13:18:30 2026-09 A211022-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-08-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211022-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-08-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211022-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-08-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211022-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-08-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211022-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211022-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-07 c2088c7a36db…2026-09-14 22:38:34 2026-08 A211022-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211022-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211022-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211022-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211022-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211022-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211022-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211022-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211022-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211022-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211022-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211022-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211022-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211022-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211022-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211022-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211022-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211022-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211022-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211022-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211022-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211022-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211022-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211022-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211022-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211022-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211022-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211022-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211022-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211022-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211022-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211022-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211022-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211022-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-08-30 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Lenalidomide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LENALIDOMIDE 2.5 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-4532-1 Lenalidomide 100 in 1 BOTTLE CAPSULE 100 6 60505-4532-2 Lenalidomide 28 in 1 BOTTLE CAPSULE 28 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-4532 LENALIDOMIDE CAPSULE [APOTEX CORP.] 5 Current NDC, 2 package rows 20240704_9943e098-20b0-dbb3-af12-7816eedd3f70.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60505-4532-2 60505453202 28 CAPSULE in 1 BOTTLE (60505-4532-2) 28 capsule 2023-03-09 No No Current