Prescription drug · NDA
Scemblix (Asciminib) NDC 0078-1196
Asciminib hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-1196-20 | 00078119620 | 60 TABLET, FILM COATED in 1 BOTTLE (0078-1196-20)Marketed from Apr 18, 2024 |
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)
- Scemblix
- Generic name (nonproprietary)
- asciminib
- Active ingredients
- Asciminib hydrochloride — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215358
- Marketing start
- Listing expires
- Identifiers
- Product ID 0078-1196_8051355d-ba0f-406e-b131-4137977f5224SPL ID 8051355d-ba0f-406e-b131-4137977f5224
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
N400078119620followed by a unit qualifier and the quantityPackage 00078-1196-20. 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 0078-1196
- What is NDC 0078-1196?
- 0078-1196 is the product NDC for Scemblix (asciminib), Asciminib hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Scemblix (Asciminib).
- What is the active ingredient?
- Asciminib hydrochloride.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Scemblix?
- 2 other product NDCs are listed under this name. See all Scemblix NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Scemblix products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Scemblixasciminib | Asciminib hydrochloride 20 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-1091 | 00078-1091-2000078-1091-94 |
| Scemblixasciminib | Asciminib hydrochloride 40 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-1098 | 00078-1098-2000078-1098-94 |
Other NDCs under NDA 215358
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 |
|---|---|---|---|---|
| Scemblixasciminib | Asciminib hydrochloride 20 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-1091 |
| Scemblixasciminib | Asciminib hydrochloride 40 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-1098 |