NDC codes

FDA NDC Directory
Product NDC (as listed)62135-659Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0659Add 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 NDC11-digit (billing)PackageCopy
62135-659-306213506593030 TABLET, FILM COATED in 1 BOTTLE (62135-659-30)Marketed from Feb 28, 2024

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
Chartwell RX, LLCNDC labeler code 62135
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208429
Marketing start
Listing expires
Other FDA classes
Bcr-Abl Tyrosine Kinase Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers
Product ID 62135-659_459cd0de-3b95-ca25-e063-6294a90a9854SPL ID 459cd0de-3b95-ca25-e063-6294a90a9854SPL set ID 65b4d8a6-349d-4fb1-9818-dad6b4ad4fa1RxCUI 403878, 403879UNII 8A1O1M485BUPC 0362135658908, 0362135659301
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

N462135065930 followed by a unit qualifier and the quantity

Package 62135-0659-30. 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 .

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 ) Ad…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62135-659

What is NDC 62135-659?
62135-659 is the product NDC for Imatinib Mesylate, Imatinib mesylate 400 mg/1 tablet, film coated, listed with the FDA by Chartwell RX, LLC. It has 1 package NDC, 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?
Chartwell RX, LLC, NDC labeler code 62135. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Imatinib MesylateImatinib mesylate 100 mg/1Tablet, Film coatedOralCivica Script LLC82249-02082249-0020-90
Imatinib MesylateImatinib mesylate 400 mg/1Tablet, Film coatedOralCivica Script LLC82249-02182249-0021-30
Imatinib MesylateimatinibImatinib mesylate 100 mg/1Tablet, Film coatedOralSafecor Health, LLC48433-04948433-0049-03
Imatinib MesylateimatinibImatinib mesylate 400 mg/1Tablet, Film coatedOralSafecor Health, LLC48433-05048433-0050-03
Imatinib MesylateImatinib mesylate 100 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-29631722-0296-90
Imatinib MesylateImatinib mesylate 400 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-29731722-0297-30
Imatinib MesylateImatinib mesylate 100 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-88260687-0882-21
Imatinib MesylateImatinib mesylate 100 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-62268001-0622-05
Imatinib MesylateImatinib mesylate 400 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-62368001-0623-04
imatinib mesylateImatinib mesylate 100 mg/1TabletOralUpsher-Smith Laboratories, LLC0832-053200832-0532-09

All 40 Imatinib Mesylate NDCs

Other NDCs under ANDA 208429

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

FDA NDC Directory listings under ANDA 208429
ProductStrengthForm · routeLabelerProduct NDC
Imatinib MesylateImatinib mesylate 100 mg/1Tablet, Film coatedOralChartwell RX, LLC62135-658

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