Home NDC 0310-0482 IRESSA
Product NDC 0310-0482
11-digit product format 003100482
Labeler code 0310
Product ID 0310-0482_508019dd-61d5-4459-9476-3f5897143f0c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gefitinib
Dosage form TABLET, COATED
Route ORAL
Labeler AstraZeneca Pharmaceuticals LP
Application NDA206995
Marketing category NDA
Marketing start 2015-07-13
Substance GEFITINIB
Active strength 250 mg/1
Pharmacologic classes Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N206995-001 IRESSA GEFITINIB 250MG TABLET / ORAL AB RLD, RS 2015-07-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N206995-001 AB
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 2 · 41 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 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206995-001 IRESSA 250MG TABLET / ORAL RLD, RS 2015-07-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206995-001 IRESSA 250MG TABLET / ORAL RLD, RS 2015-07-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206995-001 IRESSA 250MG TABLET / ORAL RLD, RS 2015-07-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206995-001 IRESSA 250MG TABLET / ORAL RLD, RS 2015-07-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206995-001 IRESSA 250MG TABLET / ORAL RLD, RS 2015-07-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206995-001 IRESSA 250MG TABLET / ORAL RLD, RS 2015-07-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206995-001 IRESSA 250MG TABLET / ORAL RLD, RS 2015-07-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206995-001 IRESSA 250MG TABLET / ORAL RLD, RS 2015-07-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206995-001 IRESSA 250MG TABLET / ORAL RLD, RS 2015-07-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206995-001 IRESSA 250MG TABLET / ORAL RLD, RS 2015-07-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206995-001 IRESSA 250MG TABLET / ORAL RLD, RS 2015-07-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206995-001 IRESSA 250MG TABLET / ORAL RLD, RS 2015-07-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206995-001 IRESSA 250MG TABLET / ORAL RLD, RS 2015-07-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206995-001 IRESSA 250MG TABLET / ORAL AB RLD, RS 2015-07-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206995-001 IRESSA 250MG TABLET / ORAL RLD, RS 2015-07-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N206995-001 IRESSA 250MG TABLET / ORAL RLD, RS 2015-07-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base IRESSA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GEFITINIB 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S65743JHBS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349472 Internal RxNorm lookup 402091 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 0310-0482-30 IRESSA 30 in 1 BOTTLE TABLET, COATED 30 19 0310-0482-93 IRESSA 30 in 1 BOTTLE TABLET, COATED 30 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GEFITINIB ACTIVE INGREDIENT S65743JHBS IRESSA (GEFITINIB) TABLET, COATED [ASTRAZENECA PHARMACEUTICALS LP] 8 GEFITINIB ACTIVE MOIETY S65743JHBS IRESSA (GEFITINIB) TABLET, COATED [ASTRAZENECA PHARMACEUTICALS LP] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U IRESSA (GEFITINIB) TABLET, COATED [ASTRAZENECA PHARMACEUTICALS LP] 8 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 IRESSA (GEFITINIB) TABLET, COATED [ASTRAZENECA PHARMACEUTICALS LP] 8 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 IRESSA (GEFITINIB) TABLET, COATED [ASTRAZENECA PHARMACEUTICALS LP] 8 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT IRESSA (GEFITINIB) TABLET, COATED [ASTRAZENECA PHARMACEUTICALS LP] 8 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IRESSA (GEFITINIB) TABLET, COATED [ASTRAZENECA PHARMACEUTICALS LP] 8 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X IRESSA (GEFITINIB) TABLET, COATED [ASTRAZENECA PHARMACEUTICALS LP] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IRESSA (GEFITINIB) TABLET, COATED [ASTRAZENECA PHARMACEUTICALS LP] 8 POLYETHYLENE GLYCOL 300 INACTIVE INGREDIENT 5655G9Y8AQ IRESSA (GEFITINIB) TABLET, COATED [ASTRAZENECA PHARMACEUTICALS LP] 8 POVIDONES INACTIVE INGREDIENT FZ989GH94E IRESSA (GEFITINIB) TABLET, COATED [ASTRAZENECA PHARMACEUTICALS LP] 8 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J IRESSA (GEFITINIB) TABLET, COATED [ASTRAZENECA PHARMACEUTICALS LP] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IRESSA (GEFITINIB) TABLET, COATED [ASTRAZENECA PHARMACEUTICALS LP] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0310-0482 IRESSA (GEFITINIB) TABLET, COATED [ASTRAZENECA PHARMACEUTICALS LP] 18 Current NDC, Legacy NDC, 2 package rows 20240517_827d60e8-7e07-41b7-c28b-49ef1c4a5a41.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 Marketing start Marketing end Sample Exclude flag Status 0310-0482-30 00310048230 30 TABLET, COATED in 1 BOTTLE (0310-0482-30) 2015-07-13 0000-00-00 No No Current 0310-0482-93 00310048293 30 in 1 BOTTLE Historical