FDA.reportPublic FDA data

IMATINIB MESYLATE

Product NDC
68180-390
11-digit product format
681800390
Labeler code
68180
Product ID
68180-390_9a08336f-337e-4024-b775-f9fd858e5168
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IMATINIB
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA207818
Marketing category
ANDA
Marketing start
2019-07-08
Marketing end
0000-00-00
Substance
IMATINIB MESYLATE
Active strength
100 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68180-390DDiscontinued by firm2026-07-31
excluded packagepackage68180-39068180-390-09DDiscontinued 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
A207818-001IMATINIB MESYLATEIMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2019-03-01
A207818-002IMATINIB MESYLATEIMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2019-03-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207818-001AB
A207818-002AB

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 22:54:322026-06A207818-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2019-03-01a50c72e98297…
2026-08-01 22:54:322026-06A207818-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2019-03-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207818-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A207818-002AB1a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-390-09EA - Each68180-3902b71497f-8282-475f-82a6-0e57c950b2b312019-07-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-390-096818003900990 TABLET, FILM COATED in 1 BOTTLE (68180-390-09) 2019-07-080000-00-00NoNoCurrent