Home NDC 69339-168 Gefitinib
Product NDC 69339-168
11-digit product format 693390168
Labeler code 69339
Product ID 69339-168_5a5b1155-767f-4e57-bd89-c67c80b40972
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gefitinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Natco Pharma USA LLC
Application ANDA212827
Marketing category ANDA
Marketing start 2023-06-05
Substance GEFITINIB
Active strength 250 mg/1
Pharmacologic classes Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
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 42 .
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 A212827-001 GEFITINIB GEFITINIB 250MG TABLET / ORAL AB 2023-05-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212827-001 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 2026-08-18 06:07:40 2026-07 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212827-001 GEFITINIB 250MG TABLET / ORAL AB 2023-05-31 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Gefitinib
Listing expiration 2027-12-31 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 69339-168-03 Gefitinib 30 in 1 BOTTLE TABLET, FILM COATED 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69339-168 GEFITINIB TABLET, FILM COATED [NATCO PHARMA USA LLC] 2 Current NDC, 1 package rows 20230928_1a3c0ce7-06a1-4e04-9106-14ddb2a866a5.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 69339-168-03 69339016803 30 TABLET, FILM COATED in 1 BOTTLE (69339-168-03) 2023-06-05 No No Current