Home NDC 59651-195 Pomalidomide
Product NDC 59651-195
11-digit product format 596510195
Labeler code 59651
Product ID 59651-195_1539fbf9-8281-4c7b-827b-9f53b50d9042
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pomalidomide
Dosage form CAPSULE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA210249
Marketing category ANDA
Marketing start 2020-10-30
Substance POMALIDOMIDE
Active strength 2 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210249-001 POMALIDOMIDE POMALIDOMIDE 1MG CAPSULE / ORAL AB 2020-10-30 A210249-002 POMALIDOMIDE POMALIDOMIDE 2MG CAPSULE / ORAL AB 2020-10-30 A210249-003 POMALIDOMIDE POMALIDOMIDE 3MG CAPSULE / ORAL AB 2020-10-30 A210249-004 POMALIDOMIDE POMALIDOMIDE 4MG CAPSULE / ORAL AB 2020-10-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 4 · 144 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 A210249-001 POMALIDOMIDE 1MG CAPSULE / ORAL AB 2020-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210249-002 POMALIDOMIDE 2MG CAPSULE / ORAL AB 2020-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210249-003 POMALIDOMIDE 3MG CAPSULE / ORAL AB 2020-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210249-004 POMALIDOMIDE 4MG CAPSULE / ORAL AB 2020-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210249-001 POMALIDOMIDE 1MG CAPSULE / ORAL 2020-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210249-002 POMALIDOMIDE 2MG CAPSULE / ORAL 2020-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210249-003 POMALIDOMIDE 3MG CAPSULE / ORAL 2020-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210249-004 POMALIDOMIDE 4MG CAPSULE / ORAL 2020-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210249-001 POMALIDOMIDE 1MG CAPSULE / ORAL 2020-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210249-002 POMALIDOMIDE 2MG CAPSULE / ORAL 2020-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210249-003 POMALIDOMIDE 3MG CAPSULE / ORAL 2020-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210249-004 POMALIDOMIDE 4MG CAPSULE / ORAL 2020-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210249-001 POMALIDOMIDE 1MG CAPSULE / ORAL 2020-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210249-002 POMALIDOMIDE 2MG CAPSULE / ORAL 2020-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210249-003 POMALIDOMIDE 3MG CAPSULE / ORAL 2020-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210249-004 POMALIDOMIDE 4MG CAPSULE / ORAL 2020-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210249-001 POMALIDOMIDE 1MG CAPSULE / ORAL 2020-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210249-002 POMALIDOMIDE 2MG CAPSULE / ORAL 2020-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210249-003 POMALIDOMIDE 3MG CAPSULE / ORAL 2020-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210249-004 POMALIDOMIDE 4MG CAPSULE / ORAL 2020-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210249-001 POMALIDOMIDE 1MG CAPSULE / ORAL 2020-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210249-002 POMALIDOMIDE 2MG CAPSULE / ORAL 2020-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210249-003 POMALIDOMIDE 3MG CAPSULE / ORAL 2020-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210249-004 POMALIDOMIDE 4MG CAPSULE / ORAL 2020-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210249-001 POMALIDOMIDE 1MG CAPSULE / ORAL 2020-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210249-002 POMALIDOMIDE 2MG CAPSULE / ORAL 2020-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210249-003 POMALIDOMIDE 3MG CAPSULE / ORAL 2020-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210249-004 POMALIDOMIDE 4MG CAPSULE / ORAL 2020-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210249-001 POMALIDOMIDE 1MG CAPSULE / ORAL 2020-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210249-002 POMALIDOMIDE 2MG CAPSULE / ORAL 2020-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210249-003 POMALIDOMIDE 3MG CAPSULE / ORAL 2020-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210249-004 POMALIDOMIDE 4MG CAPSULE / ORAL 2020-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210249-001 POMALIDOMIDE 1MG CAPSULE / ORAL 2020-10-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210249-002 POMALIDOMIDE 2MG CAPSULE / ORAL 2020-10-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210249-003 POMALIDOMIDE 3MG CAPSULE / ORAL 2020-10-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210249-004 POMALIDOMIDE 4MG CAPSULE / ORAL 2020-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210249-001 POMALIDOMIDE 1MG CAPSULE / ORAL 2020-10-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210249-002 POMALIDOMIDE 2MG CAPSULE / ORAL 2020-10-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210249-003 POMALIDOMIDE 3MG CAPSULE / ORAL 2020-10-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210249-004 POMALIDOMIDE 4MG CAPSULE / ORAL 2020-10-30 d06236e962d9…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Pomalidomide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POMALIDOMIDE 2 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1369718 Internal RxNorm lookup 1369726 Internal RxNorm lookup 1369730 Internal RxNorm lookup 1369734 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 59651-195-01 Pomalidomide 100 in 1 BOTTLE CAPSULE 100 1 59651-195-21 Pomalidomide 21 in 1 BOTTLE CAPSULE 21 1
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 Sample Exclude flag Status 59651-195-01 59651019501 100 CAPSULE in 1 BOTTLE (59651-195-01) 100 capsule 2020-10-30 No No Current 59651-195-21 59651019521 21 CAPSULE in 1 BOTTLE (59651-195-21) 21 capsule 2020-10-30 No No Current