Home NDC 43598-513 Lenalidomide
Product NDC 43598-513
11-digit product format 435980513
Labeler code 43598
Product ID 43598-513_023f2dc9-b878-9d13-44d0-894310c6b8da
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lenalidomide
Dosage form CAPSULE
Route ORAL
Labeler Dr. Reddy's Laboratories Inc.
Application ANDA209348
Marketing category ANDA
Marketing start 2022-09-07
Substance LENALIDOMIDE
Active strength 15 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 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209348-001 LENALIDOMIDE LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2021-10-14 A209348-002 LENALIDOMIDE LENALIDOMIDE 20MG CAPSULE / ORAL AB 2021-10-14 A209348-003 LENALIDOMIDE LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-08-30 A209348-004 LENALIDOMIDE LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-08-30 A209348-005 LENALIDOMIDE LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-08-30 A209348-006 LENALIDOMIDE LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-08-30
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 · 174 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 2026-02-19 14:30 UTC 2026-02 A209348-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2021-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209348-002 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2021-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209348-003 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209348-004 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209348-005 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209348-006 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209348-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2021-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209348-002 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2021-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209348-003 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209348-004 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209348-005 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209348-006 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209348-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2021-10-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209348-002 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2021-10-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209348-003 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209348-004 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209348-005 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209348-006 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209348-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2021-10-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209348-002 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2021-10-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209348-003 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209348-004 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209348-005 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209348-006 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209348-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2021-10-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209348-002 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2021-10-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209348-003 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209348-004 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209348-005 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209348-006 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209348-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2021-10-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209348-002 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2021-10-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209348-003 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-08-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209348-004 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-08-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209348-005 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2022-08-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209348-006 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2022-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209348-001 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2021-10-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209348-002 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2021-10-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209348-003 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2022-08-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209348-004 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2022-08-30 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 174 observed states.
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Lenalidomide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LENALIDOMIDE 15 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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 602910 Internal RxNorm lookup 602912 Internal RxNorm lookup 643712 Internal RxNorm lookup 643720 Internal RxNorm lookup 1242231 Internal RxNorm lookup 1428947 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 43598-513-01 Lenalidomide 100 in 1 BOTTLE CAPSULE 100 21 43598-513-21 Lenalidomide 21 in 1 BOTTLE CAPSULE 21 21
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-513 LENALIDOMIDE CAPSULE [DR. REDDY'S LABORATORIES INC.] 21 Current NDC, Legacy NDC, 2 package rows 20230902_ca8cc2cc-c856-e676-4f60-1e46d7b53d73.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 · 1 matching rows.
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 43598-513-01 43598051301 100 CAPSULE in 1 BOTTLE (43598-513-01) 100 capsule 2022-09-07 0000-00-00 No No Current 43598-513-21 43598051321 21 CAPSULE in 1 BOTTLE (43598-513-21) 21 capsule 2022-09-07 0000-00-00 No No Current