Home NDC 0480-1244 Lenalidomide
Product NDC 0480-1244
11-digit product format 004801244
Labeler code 0480
Product ID 0480-1244_f264d32e-0ed0-49b6-80f7-8009ee4803ca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lenalidomide
Dosage form CAPSULE
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application ANDA201452
Marketing category ANDA
Marketing start 2022-03-03
Substance LENALIDOMIDE
Active strength 15 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 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 A201452-001 LENALIDOMIDE LENALIDOMIDE 5MG CAPSULE / ORAL AB 2021-05-21 A201452-002 LENALIDOMIDE LENALIDOMIDE 10MG CAPSULE / ORAL AB 2021-05-21 A201452-003 LENALIDOMIDE LENALIDOMIDE 15MG CAPSULE / ORAL AB 2021-05-21 A201452-004 LENALIDOMIDE LENALIDOMIDE 25MG CAPSULE / ORAL AB 2021-05-21 A201452-005 LENALIDOMIDE LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 A201452-006 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 · 178 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 A201452-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2021-05-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201452-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2021-05-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201452-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2021-05-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201452-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2021-05-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201452-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201452-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201452-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2021-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201452-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2021-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201452-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2021-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201452-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2021-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201452-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201452-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201452-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2021-05-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201452-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2021-05-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201452-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2021-05-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201452-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2021-05-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201452-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201452-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201452-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2021-05-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201452-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2021-05-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201452-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2021-05-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201452-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2021-05-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201452-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201452-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201452-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2021-05-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201452-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2021-05-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201452-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2021-05-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201452-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2021-05-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201452-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201452-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201452-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2021-05-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201452-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2021-05-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201452-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2021-05-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201452-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2021-05-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201452-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201452-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201452-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2021-05-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201452-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2021-05-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201452-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2021-05-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201452-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2021-05-21 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 178 observed states.
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Lenalidomide
Listing expiration 2027-12-31 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 0480-1244-21 Lenalidomide 21 in 1 BOTTLE CAPSULE 21 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0480-1244 LENALIDOMIDE CAPSULE [TEVA PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20220626_1b2716cf-24b4-4157-a218-58ede63917bd.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 0480-1244-21 00480124421 21 CAPSULE in 1 BOTTLE (0480-1244-21) 21 capsule 2022-03-03 0000-00-00 No No Current