Home NDC 59572-504 Pomalyst
Product NDC 59572-504
11-digit product format 595720504
Labeler code 59572
Product ID 59572-504_4410582a-a5f3-429f-a7ca-5c17fb5560bf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pomalidomide
Dosage form CAPSULE
Route ORAL
Labeler Celgene Corporation
Application NDA204026
Marketing category NDA
Marketing start 2013-02-18
Substance POMALIDOMIDE
Active strength 4 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N204026-001 POMALYST POMALIDOMIDE 1MG CAPSULE / ORAL AB RLD 2013-02-08 N204026-002 POMALYST POMALIDOMIDE 2MG CAPSULE / ORAL AB RLD 2013-02-08 N204026-003 POMALYST POMALIDOMIDE 3MG CAPSULE / ORAL AB RLD 2013-02-08 N204026-004 POMALYST POMALIDOMIDE 4MG CAPSULE / ORAL AB RLD, RS 2013-02-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 24 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204026-001 10555939 2030-05-19 Drug product 2020-02-21 N204026-001 9993467 2030-05-19 Drug product 2018-07-11 N204026-001 10555939*PED 2030-11-19 Pediatric extension N204026-001 9993467*PED 2030-11-19 Pediatric extension N204026-001 8828427 2031-06-21 Drug substance, Drug product 2014-09-29 N204026-001 8828427*PED 2031-12-21 Pediatric extension N204026-002 10555939 2030-05-19 Drug product 2020-02-21 N204026-002 9993467 2030-05-19 Drug product 2018-07-11 N204026-002 10555939*PED 2030-11-19 Pediatric extension N204026-002 9993467*PED 2030-11-19 Pediatric extension N204026-002 8828427 2031-06-21 Drug substance, Drug product 2014-09-29 N204026-002 8828427*PED 2031-12-21 Pediatric extension N204026-003 10555939 2030-05-19 Drug product 2020-02-21 N204026-003 9993467 2030-05-19 Drug product 2018-07-11 N204026-003 10555939*PED 2030-11-19 Pediatric extension N204026-003 9993467*PED 2030-11-19 Pediatric extension N204026-003 8828427 2031-06-21 Drug substance, Drug product 2014-09-29 N204026-003 8828427*PED 2031-12-21 Pediatric extension N204026-004 10555939 2030-05-19 Drug product 2020-02-21 N204026-004 9993467 2030-05-19 Drug product 2018-07-11 N204026-004 10555939*PED 2030-11-19 Pediatric extension N204026-004 9993467*PED 2030-11-19 Pediatric extension N204026-004 8828427 2031-06-21 Drug substance, Drug product 2014-09-29 N204026-004 8828427*PED 2031-12-21 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 16 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 · 164 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 N204026-001 POMALYST 1MG CAPSULE / ORAL AB RLD 2013-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-002 POMALYST 2MG CAPSULE / ORAL AB RLD 2013-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-003 POMALYST 3MG CAPSULE / ORAL AB RLD 2013-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-004 POMALYST 4MG CAPSULE / ORAL AB RLD, RS 2013-02-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204026-001 POMALYST 1MG CAPSULE / ORAL RLD 2013-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204026-002 POMALYST 2MG CAPSULE / ORAL RLD 2013-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204026-003 POMALYST 3MG CAPSULE / ORAL RLD 2013-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204026-004 POMALYST 4MG CAPSULE / ORAL RLD, RS 2013-02-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204026-001 POMALYST 1MG CAPSULE / ORAL RLD 2013-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204026-002 POMALYST 2MG CAPSULE / ORAL RLD 2013-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204026-003 POMALYST 3MG CAPSULE / ORAL RLD 2013-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204026-004 POMALYST 4MG CAPSULE / ORAL RLD, RS 2013-02-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204026-001 POMALYST 1MG CAPSULE / ORAL AB RLD 2013-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204026-002 POMALYST 2MG CAPSULE / ORAL AB RLD 2013-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204026-003 POMALYST 3MG CAPSULE / ORAL AB RLD 2013-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204026-004 POMALYST 4MG CAPSULE / ORAL AB RLD, RS 2013-02-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204026-001 POMALYST 1MG CAPSULE / ORAL AB RLD 2013-02-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204026-002 POMALYST 2MG CAPSULE / ORAL AB RLD 2013-02-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204026-003 POMALYST 3MG CAPSULE / ORAL AB RLD 2013-02-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204026-004 POMALYST 4MG CAPSULE / ORAL AB RLD, RS 2013-02-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204026-001 POMALYST 1MG CAPSULE / ORAL AB RLD 2013-02-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204026-002 POMALYST 2MG CAPSULE / ORAL AB RLD 2013-02-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204026-003 POMALYST 3MG CAPSULE / ORAL AB RLD 2013-02-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204026-004 POMALYST 4MG CAPSULE / ORAL AB RLD, RS 2013-02-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204026-001 POMALYST 1MG CAPSULE / ORAL AB RLD 2013-02-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204026-002 POMALYST 2MG CAPSULE / ORAL AB RLD 2013-02-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204026-003 POMALYST 3MG CAPSULE / ORAL AB RLD 2013-02-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204026-004 POMALYST 4MG CAPSULE / ORAL AB RLD, RS 2013-02-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204026-001 POMALYST 1MG CAPSULE / ORAL AB RLD 2013-02-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204026-002 POMALYST 2MG CAPSULE / ORAL AB RLD 2013-02-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204026-003 POMALYST 3MG CAPSULE / ORAL AB RLD 2013-02-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204026-004 POMALYST 4MG CAPSULE / ORAL AB RLD, RS 2013-02-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204026-001 POMALYST 1MG CAPSULE / ORAL AB RLD 2013-02-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204026-002 POMALYST 2MG CAPSULE / ORAL AB RLD 2013-02-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204026-003 POMALYST 3MG CAPSULE / ORAL AB RLD 2013-02-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204026-004 POMALYST 4MG CAPSULE / ORAL AB RLD, RS 2013-02-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204026-001 POMALYST 1MG CAPSULE / ORAL AB RLD 2013-02-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204026-002 POMALYST 2MG CAPSULE / ORAL AB RLD 2013-02-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204026-003 POMALYST 3MG CAPSULE / ORAL AB RLD 2013-02-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204026-004 POMALYST 4MG CAPSULE / ORAL AB RLD, RS 2013-02-08 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Observed Orange Book patent history# Patent history page 1 of 51 · 2,036 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N204026-001 10555939 2030-05-19 Drug product 2020-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-001 9993467 2030-05-19 Drug product 2018-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-001 10555939*PED 2030-11-19 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-001 9993467*PED 2030-11-19 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-001 8828427 2031-06-21 Drug substance, Drug product 2014-09-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-001 8828427*PED 2031-12-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-002 10555939 2030-05-19 Drug product 2020-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-002 9993467 2030-05-19 Drug product 2018-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-002 10555939*PED 2030-11-19 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-002 9993467*PED 2030-11-19 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-002 8828427 2031-06-21 Drug substance, Drug product 2014-09-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-002 8828427*PED 2031-12-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-003 10555939 2030-05-19 Drug product 2020-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-003 9993467 2030-05-19 Drug product 2018-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-003 10555939*PED 2030-11-19 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-003 9993467*PED 2030-11-19 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-003 8828427 2031-06-21 Drug substance, Drug product 2014-09-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-003 8828427*PED 2031-12-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-004 10555939 2030-05-19 Drug product 2020-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-004 9993467 2030-05-19 Drug product 2018-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-004 10555939*PED 2030-11-19 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-004 9993467*PED 2030-11-19 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-004 8828427 2031-06-21 Drug substance, Drug product 2014-09-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204026-004 8828427*PED 2031-12-21 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204026-001 8198262 2025-06-17 U-2254 2018-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204026-001 8198262 2025-06-17 U-1360 2018-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204026-001 8198262*PED 2025-12-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204026-001 10555939 2030-05-19 Drug product 2020-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204026-001 9993467 2030-05-19 Drug product 2018-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204026-001 10555939*PED 2030-11-19 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204026-001 9993467*PED 2030-11-19 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204026-001 8828427 2031-06-21 Drug substance, Drug product 2014-09-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204026-001 8828427*PED 2031-12-21 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204026-002 8198262 2025-06-17 U-1360 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204026-002 8198262 2025-06-17 U-2254 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204026-002 8198262*PED 2025-12-17 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204026-002 10555939 2030-05-19 Drug product 2020-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204026-002 9993467 2030-05-19 Drug product 2018-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204026-002 10555939*PED 2030-11-19 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204026-002 9993467*PED 2030-11-19 Pediatric extension 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 21 · 836 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Pomalyst
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POMALIDOMIDE 4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D2UX06XLB5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1369718 Internal RxNorm lookup 1369724 Internal RxNorm lookup 1369726 Internal RxNorm lookup 1369728 Internal RxNorm lookup 1369730 Internal RxNorm lookup 1369732 Internal RxNorm lookup 1369734 Internal RxNorm lookup 1369736 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 59572-504-00 Pomalyst 100 in 1 BOTTLE CAPSULE 100 26 59572-504-21 Pomalyst 21 in 1 BOTTLE CAPSULE 21 26
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59572-504 POMALYST (POMALIDOMIDE) CAPSULE [CELGENE CORPORATION] 26 Current NDC, Legacy NDC, 2 package rows 20250510_2b25ef01-5c9e-11e1-b86c-0800200c9a66.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 59572-504-00 59572050400 100 CAPSULE in 1 BOTTLE (59572-504-00) 100 capsule 2013-02-18 0000-00-00 No No Current 59572-504-21 59572050421 21 CAPSULE in 1 BOTTLE (59572-504-21) 21 capsule 2013-02-18 0000-00-00 No No Current