What is NDC 60505-3629?

60505-3629 is the product NDC for Dasatinib, Dasatinib 50 mg/1 tablet, film coated, listed with the FDA by Apotex Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.

Apotex Corp., NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Dasatinib?

95 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dasatinib NDC 60505-3629 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)60505-3629Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60505-3629Add 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
60505-3629-6	6050536290660505362906	60 TABLET, FILM COATED in 1 BOTTLE (60505-3629-6)Marketed from Sep 3, 2024

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): Dasatinib
Generic name (nonproprietary): dasatinib
Active ingredients: Dasatinib — 50 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Apotex Corp.NDC labeler code 60505
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202103
Marketing start: Sep 3, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 3A4 Inhibitors (Mechanism)Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 60505-3629_ec5a2f19-c89e-c4cd-c819-a22c585d18b4SPL ID ec5a2f19-c89e-c4cd-c819-a22c585d18b4SPL set ID 2ed87763-f018-abdb-c0ab-daa5e441b397RxCUI 643105, 643107, 643109, 799047, 1045402, 1045406UNII RBZ1571X5HUPC 0360505381630, 0360505363063
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

N460505362906 followed by a unit qualifier and the quantity

Package 60505-3629-06. 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 4, 2024.

Indications (excerpt from the label)

Dasatinib tablets are indicated for the treatment of adult patients with • newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. • chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. • Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy. Dasatinib is a kinase inhibitor indicated for the treatment of newly diagnosed…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 60505-3629

What is NDC 60505-3629?: 60505-3629 is the product NDC for Dasatinib, Dasatinib 50 mg/1 tablet, film coated, listed with the FDA by Apotex Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dasatinib.
What is the active ingredient?: Dasatinib.
Who is the labeler?: Apotex Corp., NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dasatinib?: 95 other product NDCs are listed under this name. See all Dasatinib 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 Dasatinib NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Dasatinib	Dasatinib 20 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-192	82009-0192-60
Dasatinib	Dasatinib 100 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-196	82009-0196-30
Dasatinib	Dasatinib 50 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-193	82009-0193-60
Dasatinib	Dasatinib 70 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-194	82009-0194-60
Dasatinib	Dasatinib 80 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-195	82009-0195-30
Dasatinib	Dasatinib 140 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-197	82009-0197-30
Dasatinib	Dasatinib 20 mg/1	TabletOral	Novadoz Pharmaceuticals LLC	72205-319	72205-0319-60
Dasatinib	Dasatinib 100 mg/1	TabletOral	Novadoz Pharmaceuticals LLC	72205-323	72205-0323-30
Dasatinib	Dasatinib 50 mg/1	TabletOral	Novadoz Pharmaceuticals LLC	72205-320	72205-0320-60
Dasatinib	Dasatinib 70 mg/1	TabletOral	Novadoz Pharmaceuticals LLC	72205-321	72205-0321-60

All 96 Dasatinib NDCs

Other NDCs under ANDA 202103

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

FDA NDC Directory listings under ANDA 202103
Product	Strength	Form · route	Labeler	Product NDC
Dasatinib	Dasatinib 20 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3628
Dasatinib	Dasatinib 70 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3630
Dasatinib	Dasatinib 100 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3631