Home DailyMed d070f0e7-2d9d-4a74-af57-e76823f09f9e National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2013-03-03
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 04:02:06 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 172 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 N204026-001 POMALYST 1MG CAPSULE / ORAL AB RLD 2013-02-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-002 POMALYST 2MG CAPSULE / ORAL AB RLD 2013-02-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-003 POMALYST 3MG CAPSULE / ORAL AB RLD 2013-02-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-004 POMALYST 4MG CAPSULE / ORAL AB RLD, RS 2013-02-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204026-001 POMALYST 1MG CAPSULE / ORAL AB RLD 2013-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204026-002 POMALYST 2MG CAPSULE / ORAL AB RLD 2013-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204026-003 POMALYST 3MG CAPSULE / ORAL AB RLD 2013-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204026-004 POMALYST 4MG CAPSULE / ORAL AB RLD, RS 2013-02-08 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 92 observed states.
Observed Orange Book patent history# Patent history page 1 of 53 · 2,084 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N204026-001 10555939 2030-05-19 Drug product 2020-02-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-001 9993467 2030-05-19 Drug product 2018-07-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-001 10555939*PED 2030-11-19 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-001 9993467*PED 2030-11-19 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-001 8828427 2031-06-21 Drug substance, Drug product 2014-09-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-001 8828427*PED 2031-12-21 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-002 10555939 2030-05-19 Drug product 2020-02-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-002 9993467 2030-05-19 Drug product 2018-07-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-002 10555939*PED 2030-11-19 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-002 9993467*PED 2030-11-19 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-002 8828427 2031-06-21 Drug substance, Drug product 2014-09-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-002 8828427*PED 2031-12-21 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-003 10555939 2030-05-19 Drug product 2020-02-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-003 9993467 2030-05-19 Drug product 2018-07-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-003 10555939*PED 2030-11-19 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-003 9993467*PED 2030-11-19 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-003 8828427 2031-06-21 Drug substance, Drug product 2014-09-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-003 8828427*PED 2031-12-21 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-004 10555939 2030-05-19 Drug product 2020-02-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-004 9993467 2030-05-19 Drug product 2018-07-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-004 10555939*PED 2030-11-19 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-004 9993467*PED 2030-11-19 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-004 8828427 2031-06-21 Drug substance, Drug product 2014-09-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204026-004 8828427*PED 2031-12-21 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204026-001 10555939 2030-05-19 Drug product 2020-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204026-001 9993467 2030-05-19 Drug product 2018-07-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204026-001 10555939*PED 2030-11-19 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204026-001 9993467*PED 2030-11-19 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204026-001 8828427 2031-06-21 Drug substance, Drug product 2014-09-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204026-001 8828427*PED 2031-12-21 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204026-002 10555939 2030-05-19 Drug product 2020-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204026-002 9993467 2030-05-19 Drug product 2018-07-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204026-002 10555939*PED 2030-11-19 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204026-002 9993467*PED 2030-11-19 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204026-002 8828427 2031-06-21 Drug substance, Drug product 2014-09-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204026-002 8828427*PED 2031-12-21 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204026-003 10555939 2030-05-19 Drug product 2020-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204026-003 9993467 2030-05-19 Drug product 2018-07-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204026-003 10555939*PED 2030-11-19 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204026-003 9993467*PED 2030-11-19 Pediatric extension caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 22 · 868 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.