What is NDC 67184-0533?

67184-0533 is the product NDC for imatinib mesylate, Imatinib mesylate 400 mg/1 tablet, listed with the FDA by Qilu Pharmaceutical Co., Ltd.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Qilu Pharmaceutical Co., Ltd., NDC labeler code 67184. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for imatinib mesylate?

39 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

imatinib mesylate NDC 67184-0533 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)67184-0533Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67184-0533Add 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
67184-0533-1	6718405330167184053301	30 TABLET in 1 BOTTLE (67184-0533-1)Marketed from Jun 21, 2022
67184-0533-2	6718405330267184053302	300 TABLET in 1 BOTTLE (67184-0533-2)Marketed from Jun 21, 2022
67184-0533-3	6718405330367184053303	30 BLISTER PACK in 1 CARTON (67184-0533-3) / 10 TABLET in 1 BLISTER PACKMarketed from Jun 21, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Route: Oral
Labeler: Qilu Pharmaceutical Co., Ltd.NDC labeler code 67184
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212135
Marketing start: Jun 21, 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 67184-0533_a41dbedd-ee4e-401c-b446-a435929ff903SPL ID a41dbedd-ee4e-401c-b446-a435929ff903SPL set ID 82eb01e0-8685-4f06-8a72-7663e8ded38fRxCUI 403878, 403879UNII 8A1O1M485BUPC 0367184053322, 0367184053223
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

N467184053301 followed by a unit qualifier and the quantity

Package 67184-0533-01. 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 Dec 4, 2024.

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)

About NDC 67184-0533

What is NDC 67184-0533?: 67184-0533 is the product NDC for imatinib mesylate, Imatinib mesylate 400 mg/1 tablet, listed with the FDA by Qilu Pharmaceutical Co., Ltd.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: imatinib mesylate.
What is the active ingredient?: Imatinib mesylate.
Who is the labeler?: Qilu Pharmaceutical Co., Ltd., NDC labeler code 67184. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for imatinib mesylate?: 39 other product NDCs are listed under this name. See all imatinib mesylate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other imatinib mesylate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Imatinib Mesylate	Imatinib mesylate 100 mg/1	Tablet, Film coatedOral	Civica Script LLC	82249-020	82249-0020-90
Imatinib Mesylate	Imatinib mesylate 400 mg/1	Tablet, Film coatedOral	Civica Script LLC	82249-021	82249-0021-30
Imatinib Mesylateimatinib	Imatinib mesylate 100 mg/1	Tablet, Film coatedOral	Safecor Health, LLC	48433-049	48433-0049-03
Imatinib Mesylateimatinib	Imatinib mesylate 400 mg/1	Tablet, Film coatedOral	Safecor Health, LLC	48433-050	48433-0050-03
Imatinib Mesylate	Imatinib mesylate 100 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-296	31722-0296-90
Imatinib Mesylate	Imatinib mesylate 400 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-297	31722-0297-30
Imatinib Mesylate	Imatinib mesylate 100 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-882	60687-0882-21
Imatinib Mesylate	Imatinib mesylate 100 mg/1	Tablet, Film coatedOral	BluePoint Laboratories	68001-622	68001-0622-05
Imatinib Mesylate	Imatinib mesylate 400 mg/1	Tablet, Film coatedOral	BluePoint Laboratories	68001-623	68001-0623-04
imatinib mesylate	Imatinib mesylate 100 mg/1	TabletOral	Upsher-Smith Laboratories, LLC	0832-0532	00832-0532-09

All 40 imatinib mesylate NDCs

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 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 100 mg/1	TabletOral	Archis Pharma LLC	72819-185
imatinib mesylate	Imatinib mesylate 400 mg/1	TabletOral	Archis Pharma LLC	72819-186