Sprycel (dasatinib) NDC 0003-0528

NDC codes

FDA NDC Directory

Product NDC (as listed)0003-0528Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00003-0528Add 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
0003-0528-11	00003052811	1 BOTTLE in 1 CARTON (0003-0528-11) / 60 TABLET in 1 BOTTLEMarketed from Jun 27, 2006

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Sprycel
Generic name (nonproprietary): dasatinib
Active ingredients: Dasatinib — 50 mg/1
Dosage form: Tablet
Route: Oral
Labeler: E.R. Squibb & Sons, L.L.C.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021986
Marketing start: Jun 27, 2006
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 3A4 Inhibitors (Mechanism)Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 0003-0528_a1c91e1f-f43d-4b65-b952-cd230c3f8f2fSPL ID a1c91e1f-f43d-4b65-b952-cd230c3f8f2f
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

N400003052811 followed by a unit qualifier and the quantity

Package 00003-0528-11. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under NDA 021986

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

FDA NDC Directory listings under NDA 021986
Product	Strength	Form · route	Labeler	Product NDC
Spryceldasatinib	Dasatinib 70 mg/1	TabletOral	E.R. Squibb & Sons, L.L.C.	0003-0524
Spryceldasatinib	Dasatinib 140 mg/1	TabletOral	E.R. Squibb & Sons, L.L.C.	0003-0857
Spryceldasatinib	Dasatinib 100 mg/1	TabletOral	E.R. Squibb & Sons, L.L.C.	0003-0852
Spryceldasatinib	Dasatinib 20 mg/1	TabletOral	E.R. Squibb & Sons, L.L.C.	0003-0527
Dasatinib	Dasatinib 20 mg/1	TabletOral	Prasco Laboratories	66993-233
Dasatinib	Dasatinib 100 mg/1	TabletOral	Prasco Laboratories	66993-237
Dasatinib	Dasatinib 50 mg/1	TabletOral	Prasco Laboratories	66993-234
Dasatinib	Dasatinib 70 mg/1	TabletOral	Prasco Laboratories	66993-235
Dasatinib	Dasatinib 80 mg/1	TabletOral	Prasco Laboratories	66993-236
Dasatinib	Dasatinib 140 mg/1	TabletOral	Prasco Laboratories	66993-238
Spryceldasatinib	Dasatinib 80 mg/1	TabletOral	E.R. Squibb & Sons, L.L.C.	0003-0855