Home NDC 0480-4053 Gefitinib
Product NDC 0480-4053
11-digit product format 004804053
Labeler code 0480
Product ID 0480-4053_6e61cabd-272d-4d08-a42b-41dcf3e631fd
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
Marketing end 2027-07-31
Substance GEFITINIB
Active strength 250 mg/1
Pharmacologic classes Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 2026-10-15 13:18:30 2026-09 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 c2088c7a36db…2026-09-14 22:38:34 2026-08 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208913-001 GEFITINIB 250MG TABLET / ORAL AB 2023-04-26 caaa826d4ba7…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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Gefitinib Active Ingredients# Ingredient, Strength table Ingredient Strength GEFITINIB 250 mg/1
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
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 0480-4053-56 00480405356 30 TABLET, FILM COATED in 1 BOTTLE (0480-4053-56) 2023-06-21 2027-07-31 No No Historical