imatinib mesylate NDC 72819-185

NDC codes

FDA NDC Directory

Product NDC (as listed)72819-185Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72819-0185Add 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
72819-185-09	72819018509	90 TABLET in 1 BOTTLE (72819-185-09)Marketed from Sep 1, 2022

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 — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Archis Pharma LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212135
Marketing start: Sep 1, 2022
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 72819-185_05dbf49e-73b7-3190-e063-6394a90a1a64SPL ID 05dbf49e-73b7-3190-e063-6394a90a1a64SPL set ID 9de8d8b9-cf88-4960-82b7-89e5ceb7720eRxCUI 403878, 403879UNII 8A1O1M485BUPC 0372819185095, 0372819186030
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

N472819018509 followed by a unit qualifier and the quantity

Package 72819-0185-09. 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 tablets are 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. (…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212135

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

FDA NDC Directory listings under ANDA 212135
Product	Strength	Form · route	Labeler	Product NDC
imatinib mesylate	Imatinib mesylate 400 mg/1	TabletOral	Archis Pharma LLC	72819-186
imatinib mesylate	Imatinib mesylate 100 mg/1	TabletOral	Upsher-Smith Laboratories, LLC	0832-0532
imatinib mesylate	Imatinib mesylate 400 mg/1	TabletOral	Upsher-Smith Laboratories, LLC	0832-0533
imatinib mesylate	Imatinib mesylate 100 mg/1	TabletOral	Qilu Pharmaceutical Co., Ltd.	67184-0532
imatinib mesylate	Imatinib mesylate 400 mg/1	TabletOral	Qilu Pharmaceutical Co., Ltd.	67184-0533