FDA.reportPublic FDA data

imatinib mesylate

Product NDC
67184-0532
Requested package NDC
67184-0532-1
11-digit product format
671840532
Labeler code
67184
Product ID
67184-0532_a41dbedd-ee4e-401c-b446-a435929ff903
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
imatinib mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Qilu Pharmaceutical Co., Ltd.
Application
ANDA212135
Marketing category
ANDA
Marketing start
2022-06-21
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
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212135-001IMATINIB MESYLATEIMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2022-06-21
A212135-002IMATINIB MESYLATEIMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2022-06-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A212135-001AB
A212135-002AB

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 22:54:322026-06A212135-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2022-06-21a50c72e98297…
2026-08-01 22:54:322026-06A212135-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2022-06-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212135-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A212135-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
imatinib mesylateIMATINIB MESYLATEUpsher-Smith Laboratories, LLC5d07ac08-962e-41a8-8a3c-50febc8c5f342026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212135
application number: ANDA212135
imatinib mesylateIMATINIB MESYLATEQilu Pharmaceutical Co., Ltd.82eb01e0-8685-4f06-8a72-7663e8ded38f2024-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212135
application number: ANDA212135
ndc (package): 67184-0532-1
ndc (product): 67184-0532
ndc11 (package): 67184053201
imatinib mesylateIMATINIB MESYLATEArchis Pharma LLC9de8d8b9-cf88-4960-82b7-89e5ceb7720e2023-09-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212135
application number: ANDA212135

Additional Listing Data#

Finished product
Yes
Brand name base
imatinib mesylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IMATINIB MESYLATE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8A1O1M485BInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
403878Internal RxNorm lookup
403879Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
82eb01e0-8685-4f06-8a72-7663e8ded38fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d2ca280-d5c0-49b4-9bbd-0191c7e031beProduct name120250724
a07e1ba8-e0e6-1fcb-b05d-47e31d308a05Product name920230314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67184-0532-1imatinib mesylate90 in 1 BOTTLETABLET9035
67184-0532-2imatinib mesylate500 in 1 BOTTLETABLET50035
67184-0532-3imatinib mesylate10 in 1 BLISTER PACKTABLET1035
67184-0532-3imatinib mesylate30 in 1 CARTONTABLET3035

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67184-0532IMATINIB MESYLATE TABLET [QILU PHARMACEUTICAL CO., LTD.]35Current NDC, Legacy NDC, 4 package rows20241207_82eb01e0-8685-4f06-8a72-7663e8ded38f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403878imatinib mesylate 100 MG Oral TabletPSN82eb01e0-8685-4f06-8a72-7663e8ded38f35
403879imatinib mesylate 400 MG Oral TabletPSN82eb01e0-8685-4f06-8a72-7663e8ded38f35
403878imatinib 100 MG Oral TabletSCD82eb01e0-8685-4f06-8a72-7663e8ded38f35
403879imatinib 400 MG Oral TabletSCD82eb01e0-8685-4f06-8a72-7663e8ded38f35
403878imatinib (as imatinib mesylate) 100 MG Oral TabletSY82eb01e0-8685-4f06-8a72-7663e8ded38f35
403879imatinib (as imatinib mesylate) 400 MG Oral TabletSY82eb01e0-8685-4f06-8a72-7663e8ded38f35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67184-0532-16718405320190 TABLET in 1 BOTTLE (67184-0532-1) 90 tablet2022-06-210000-00-00NoNoCurrent