Home NDC 82249-020 IMATINIB MESYLATE
Product NDC 82249-020
11-digit product format 822490020
Labeler code 82249
Product ID 82249-020_55b02662-941b-be69-e063-6294a90aeafd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name IMATINIB MESYLATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Civica Script LLC
Application ANDA212975
Marketing category ANDA
Marketing start 2026-07-03
Substance IMATINIB MESYLATE
Active strength 100 mg/1
Pharmacologic classes Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]
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 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212975-001 IMATINIB MESYLATE IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2025-04-14 A212975-002 IMATINIB MESYLATE IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2025-04-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2026-09-14 22:38:34 2026-08 A212975-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2025-04-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212975-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2025-04-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212975-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2025-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212975-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2025-04-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212975-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2025-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212975-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2025-04-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212975-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2025-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212975-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2025-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212975-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2025-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212975-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2025-04-14 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212975-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2025-04-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212975-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2025-04-14 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 IMATINIB MESYLATE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IMATINIB MESYLATE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8A1O1M485B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 403878 Internal RxNorm lookup 403879 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82249-020-90 82249002090 90 TABLET, FILM COATED in 1 BOTTLE (82249-020-90) 2026-07-03 No No Current