Home NDC 0480-4053 Gefitinib
Product NDC 0480-4053
11-digit product format 004804053
Labeler code 0480
Product ID 0480-4053_94ce2dc4-2b69-4c50-b53e-21e24062903d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gefitinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application ANDA208913
Marketing category ANDA
Marketing start 2023-06-21
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 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 A208913-001 GEFITINIB GEFITINIB 250MG TABLET / ORAL AB 2023-04-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208913-001 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.
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 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Gefitinib
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349472 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 0480-4053-56 Gefitinib 30 in 1 BOTTLE TABLET, FILM COATED 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0480-4053 GEFITINIB TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] 5 Current NDC, 1 package rows 20241215_3dd135f0-5db1-4236-9756-04533b66dc9d.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 Sample Exclude flag Status 0480-4053-56 00480405356 30 TABLET, FILM COATED in 1 BOTTLE (0480-4053-56) 2023-06-21 No No Current