Prescription drug · NDA
Sprycel (Dasatinib) NDC 0003-0857
Dasatinib 140 mg/1 · Tablet · Oral · E.R. Squibb & Sons, L.L.C.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0003-0857-22 | 0000308572200003085722 | 1 BOTTLE in 1 CARTON (0003-0857-22) / 30 TABLET in 1 BOTTLEMarketed from Oct 28, 2010 |
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 — 140 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- E.R. Squibb & Sons, L.L.C.NDC labeler code 0003
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021986
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 3A4 Inhibitors (Mechanism)Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 0003-0857_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
N400003085722followed by a unit qualifier and the quantityPackage 00003-0857-22. 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.
About NDC 0003-0857
- What is NDC 0003-0857?
- 0003-0857 is the product NDC for Sprycel (dasatinib), Dasatinib 140 mg/1 tablet, listed with the FDA by E.R. Squibb & Sons, L.L.C.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sprycel (Dasatinib).
- What is the active ingredient?
- Dasatinib.
- Who is the labeler?
- E.R. Squibb & Sons, L.L.C., NDC labeler code 0003. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sprycel?
- 5 other product NDCs are listed under this name. See all Sprycel NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sprycel products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Spryceldasatinib | Dasatinib 80 mg/1 | TabletOral | E.R. Squibb & Sons, L.L.C. | 0003-0855 | 00003-0855-22 |
| Spryceldasatinib | Dasatinib 100 mg/1 | TabletOral | E.R. Squibb & Sons, L.L.C. | 0003-0852 | 00003-0852-22 |
| Spryceldasatinib | Dasatinib 70 mg/1 | TabletOral | E.R. Squibb & Sons, L.L.C. | 0003-0524 | 00003-0524-11 |
| Spryceldasatinib | Dasatinib 20 mg/1 | TabletOral | E.R. Squibb & Sons, L.L.C. | 0003-0527 | 00003-0527-11 |
| Spryceldasatinib | Dasatinib 50 mg/1 | TabletOral | E.R. Squibb & Sons, L.L.C. | 0003-0528 | 00003-0528-11 |
Other NDCs under NDA 021986
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dasatinib | Dasatinib 20 mg/1 | TabletOral | Prasco Laboratories | 66993-233 |
| 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 100 mg/1 | TabletOral | Prasco Laboratories | 66993-237 |
| Dasatinib | Dasatinib 140 mg/1 | TabletOral | Prasco Laboratories | 66993-238 |
| Spryceldasatinib | Dasatinib 70 mg/1 | TabletOral | E.R. Squibb & Sons, L.L.C. | 0003-0524 |
| Spryceldasatinib | Dasatinib 20 mg/1 | TabletOral | E.R. Squibb & Sons, L.L.C. | 0003-0527 |
| Spryceldasatinib | Dasatinib 50 mg/1 | TabletOral | E.R. Squibb & Sons, L.L.C. | 0003-0528 |
| Spryceldasatinib | Dasatinib 100 mg/1 | TabletOral | E.R. Squibb & Sons, L.L.C. | 0003-0852 |
| Spryceldasatinib | Dasatinib 80 mg/1 | TabletOral | E.R. Squibb & Sons, L.L.C. | 0003-0855 |