imatinib mesylate NDC 68001-491

NDC codes

FDA NDC Directory

Product NDC (as listed)68001-491Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68001-0491Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
68001-491-04	68001049104	30 TABLET, FILM COATED in 1 BOTTLE (68001-491-04)Marketed from Mar 26, 2021

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): imatinib mesylate
Generic name (nonproprietary): imatinib mesylate
Active ingredients: Imatinib mesylate — 400 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: BluePoint Laboratories
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078340
Marketing start: Mar 26, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Bcr-Abl Tyrosine Kinase Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers: Product ID 68001-491_05c9d227-d639-916a-e063-6294a90a66a6SPL ID 05c9d227-d639-916a-e063-6294a90a66a6SPL set ID be5b9047-155b-59ca-e053-2995a90ad3dcRxCUI 403878, 403879UNII 8A1O1M485BUPC 0368001490054, 0368001491044
Pharmacologic class: Kinase Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468001049104 followed by a unit qualifier and the quantity

Package 68001-0491-04. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Sep 21, 2023.

Indications (excerpt from the label)

Imatinib mesylate is a kinase inhibitor indicated for the treatment of: Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1 ) Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. ( 1.2 ) Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). ( 1.3 ) Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4) Adul…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078340

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078340
Product	Strength	Form · route	Labeler	Product NDC
imatinib mesylate	Imatinib mesylate 100 mg/1	Tablet, Film coatedOral	BluePoint Laboratories	68001-490
imatinib mesylate	Imatinib mesylate 100 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-472
imatinib mesylate	Imatinib mesylate 400 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-475