FDA.reportPublic FDA data

Imatinib Mesylate

Product NDC
65162-794
Requested package NDC
65162-794-03
11-digit product format
651620794
Labeler code
65162
Product ID
65162-794_86a4b0ad-816a-4768-aecd-0fe4a39e51ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imatinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA207495
Marketing category
ANDA
Marketing start
2019-02-08
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage65162-79465162-794-03DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207495-001IMATINIB MESYLATEIMATINIB MESYLATEEQ 100MG BASETABLET / ORAL2019-02-08
A207495-002IMATINIB MESYLATEIMATINIB MESYLATEEQ 400MG BASETABLET / ORAL2019-02-08

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A207495-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORAL2019-02-08a50c72e98297…
2026-08-01 22:54:322026-06A207495-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORAL2019-02-08a50c72e98297…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-794IMATINIB MESYLATE (IMATINIB) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC]25Legacy NDC20241027_1139f461-dc02-45f0-b8fd-70552315c6d6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-794-036516207940330 TABLET, FILM COATED in 1 BOTTLE (65162-794-03) 2019-02-080000-00-00NoNoCurrent