Home NDC 60505-4537-1 Lenalidomide
Product NDC 60505-4537
Requested package NDC 60505-4537-1
11-digit product format 605054537
Labeler code 60505
Product ID 60505-4537_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 2022-09-06
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 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 · 166 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 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…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211022-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211022-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211022-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211022-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211022-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211022-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-08-30 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 166 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 25 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-4537-1 Lenalidomide 100 in 1 BOTTLE CAPSULE 100 6 60505-4537-2 Lenalidomide 21 in 1 BOTTLE CAPSULE 21 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-4537 LENALIDOMIDE CAPSULE [APOTEX CORP.] 5 Current NDC, Legacy 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 Marketing end Sample Exclude flag Status 60505-4537-1 60505453701 100 CAPSULE in 1 BOTTLE (60505-4537-1) 100 capsule 2022-09-06 0000-00-00 No No Current