IMATINIB MESYLATE

Product NDC: 68180-390
Requested package NDC: 68180-390-09
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68180-390	68180-390-09	D	Discontinued by firm		2026-07-31

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207818-001	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB		2019-03-01
A207818-002	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB		2019-03-01

Therapeutic equivalence codes#

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

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

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
2026-08-01 22:54:32	2026-06	A207818-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB		2019-03-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207818-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB		2019-03-01	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A207818-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207818-002	AB	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-390-09	EA - Each	68180-390	2b71497f-8282-475f-82a6-0e57c950b2b3	1	2019-07-02

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8A1O1M485B	IMATINIB MESYLATE	220127-57-1	IMATINIB MESYLATE
BKJ8M8G5HI	IMATINIB	152459-95-5	IMATINIB

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-390-09	68180039009	90 TABLET, FILM COATED in 1 BOTTLE (68180-390-09)	2019-07-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
IMATINIB MESYLATE	Lupin Pharmaceuticals, Inc. \| Natco Pharma Limited-Pharma Division	2020-10-21	Human Prescription Drug Label	4