FDA.reportPublic FDA data

Imatinib Mesylate

Product NDC
0378-2245
11-digit product format
003782245
Labeler code
0378
Product ID
0378-2245_a88e0c38-cbf6-4e41-af11-623228830c34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
imatinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA204644
Marketing category
ANDA
Marketing start
2017-09-28
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 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
A204644-001IMATINIB MESYLATEIMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2017-06-21
A204644-002IMATINIB MESYLATEIMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2017-06-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204644-001AB
A204644-002AB

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 22:54:322026-06A204644-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2017-06-21a50c72e98297…
2026-08-01 22:54:322026-06A204644-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2017-06-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204644-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204644-002AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Imatinib MesylateIMATINIBGolden State Medical Supply, Inc.9131b2ce-752d-3a30-e053-2a95a90adaab2026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204644
application number: ANDA204644
Imatinib MesylateIMATINIBMylan Pharmaceuticals Inc.a1787fad-3612-43e1-98fa-ce62361e0b3c2026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204644
application number: ANDA204644
ndc (product): 0378-2245
Imatinib MesylateIMATINIBSafecor Health, LLCf4acacbd-13f8-4a46-b615-b639a17f331f2026-04-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204644
application number: ANDA204644
Imatinib MesylateIMATINIBMylan Institutional Inc1debf3a0-7587-47d7-8ea6-e739698d72972025-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204644
application number: ANDA204644

Additional Listing Data#

Finished product
Yes
Brand name base
Imatinib Mesylate
Listing expiration
2027-12-31

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
a1787fad-3612-43e1-98fa-ce62361e0b3cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d2ca280-d5c0-49b4-9bbd-0191c7e031beProduct name120250724
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a07e1ba8-e0e6-1fcb-b05d-47e31d308a05Product name920230314
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-2245-77Imatinib Mesylate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-2245-77EA - Each0378-22458fd28923-465a-40ca-a6d2-c3aaa33abb9212017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-2245IMATINIB MESYLATE (IMATINIB) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]15Current NDC, Legacy NDC, 1 package rows20240511_a1787fad-3612-43e1-98fa-ce62361e0b3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403878imatinib mesylate 100 MG Oral TabletPSNa1787fad-3612-43e1-98fa-ce62361e0b3c16
403879imatinib mesylate 400 MG Oral TabletPSNa1787fad-3612-43e1-98fa-ce62361e0b3c16
403878imatinib 100 MG Oral TabletSCDa1787fad-3612-43e1-98fa-ce62361e0b3c16
403879imatinib 400 MG Oral TabletSCDa1787fad-3612-43e1-98fa-ce62361e0b3c16
403878imatinib (as imatinib mesylate) 100 MG Oral TabletSYa1787fad-3612-43e1-98fa-ce62361e0b3c16
403879imatinib (as imatinib mesylate) 400 MG Oral TabletSYa1787fad-3612-43e1-98fa-ce62361e0b3c16
403878imatinib mesylate 100 MG Oral TabletPSN1debf3a0-7587-47d7-8ea6-e739698d729715
403879imatinib mesylate 400 MG Oral TabletPSN1debf3a0-7587-47d7-8ea6-e739698d729715
403878imatinib 100 MG Oral TabletSCD1debf3a0-7587-47d7-8ea6-e739698d729715
403879imatinib 400 MG Oral TabletSCD1debf3a0-7587-47d7-8ea6-e739698d729715
403878imatinib (as imatinib mesylate) 100 MG Oral TabletSY1debf3a0-7587-47d7-8ea6-e739698d729715
403879imatinib (as imatinib mesylate) 400 MG Oral TabletSY1debf3a0-7587-47d7-8ea6-e739698d729715
403878imatinib mesylate 100 MG Oral TabletPSN9131b2ce-752d-3a30-e053-2a95a90adaab7
403879imatinib mesylate 400 MG Oral TabletPSN9131b2ce-752d-3a30-e053-2a95a90adaab7
403878imatinib 100 MG Oral TabletSCD9131b2ce-752d-3a30-e053-2a95a90adaab7
403879imatinib 400 MG Oral TabletSCD9131b2ce-752d-3a30-e053-2a95a90adaab7
403878imatinib (as imatinib mesylate) 100 MG Oral TabletSY9131b2ce-752d-3a30-e053-2a95a90adaab7
403879imatinib (as imatinib mesylate) 400 MG Oral TabletSY9131b2ce-752d-3a30-e053-2a95a90adaab7
403878imatinib mesylate 100 MG Oral TabletPSNf4acacbd-13f8-4a46-b615-b639a17f331f2
403879imatinib mesylate 400 MG Oral TabletPSNf4acacbd-13f8-4a46-b615-b639a17f331f2
403878imatinib 100 MG Oral TabletSCDf4acacbd-13f8-4a46-b615-b639a17f331f2
403879imatinib 400 MG Oral TabletSCDf4acacbd-13f8-4a46-b615-b639a17f331f2
403878imatinib (as imatinib mesylate) 100 MG Oral TabletSYf4acacbd-13f8-4a46-b615-b639a17f331f2
403879imatinib (as imatinib mesylate) 400 MG Oral TabletSYf4acacbd-13f8-4a46-b615-b639a17f331f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-2245-770037822457790 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2245-77) 2017-09-280000-00-00NoNoCurrent