Home NDC 69097-604 Lenalidomide
Product NDC 69097-604
11-digit product format 690970604
Labeler code 69097
Product ID 69097-604_8eeb4be1-20a8-4250-b002-ec6705fb1e18
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lenalidomide
Dosage form CAPSULE
Route ORAL
Labeler Cipla USA Inc.
Application ANDA214618
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 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214618-001 LENALIDOMIDE LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214618-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214618-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Lenalidomide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LENALIDOMIDE 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F0P408N6V4 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1242231 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69097-604-73 Lenalidomide 28 in 1 BOTTLE CAPSULE 28 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-604 LENALIDOMIDE CAPSULE [CIPLA USA INC.] 1 Current NDC, 1 package rows 20230310_96df285d-dd13-4083-b2c6-e5c799e7587b.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69097-604-73 69097060473 28 CAPSULE in 1 BOTTLE (69097-604-73) 28 capsule 2023-03-09 No No Current