Home NDC 67184-0531 Gefitinib
Product NDC 67184-0531
11-digit product format 671840531
Labeler code 67184
Product ID 67184-0531_8aa73f33-2813-4dfa-939f-e4291081449a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gefitinib
Dosage form TABLET, COATED
Route ORAL
Labeler Qilu Pharmaceutical Co., Ltd.
Application ANDA211591
Marketing category ANDA
Marketing start 2023-02-13
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 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 A211591-001 GEFITINIB GEFITINIB 250MG TABLET / ORAL AB 2023-02-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211591-001 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 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211591-001 GEFITINIB 250MG TABLET / ORAL AB 2023-02-13 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 67184-0531-1 Gefitinib 30 in 1 BOTTLE TABLET, COATED 30 7 67184-0531-2 Gefitinib 500 in 1 BOTTLE TABLET, COATED 500 7 67184-0531-3 Gefitinib 3 in 1 CARTON TABLET, COATED 3 7 67184-0531-3 Gefitinib 10 in 1 BLISTER PACK TABLET, COATED 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67184-0531 GEFITINIB TABLET, COATED [QILU PHARMACEUTICAL CO., LTD.] 7 Current NDC, 4 package rows 20230223_0afc12dd-12f8-4def-9027-f38412a862b9.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 · 2 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 67184-0531-1 67184053101 30 TABLET, COATED in 1 BOTTLE (67184-0531-1) 2023-02-13 No No Current 67184-0531-2 67184053102 500 TABLET, COATED in 1 BOTTLE (67184-0531-2) 2023-02-13 No No Current 67184-0531-3 67184053103 3 BLISTER PACK in 1 CARTON (67184-0531-3) / 10 TABLET, COATED in 1 BLISTER PACK 3 blister pack 2023-02-13 No No Current