Prescription drug · NDA
Truqap (Capivasertib) NDC 0310-9500
Capivasertib 160 mg/1 · Tablet, Film coated · Oral · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0310-9500-01 | 0031095000100310950001 | 64 TABLET, FILM COATED in 1 BOTTLE (0310-9500-01)Marketed from Nov 16, 2023 | |
| 0310-9500-02 | 0031095000200310950002 | 4 BLISTER PACK in 1 CARTON (0310-9500-02) / 16 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 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)
- Truqap
- Generic name (nonproprietary)
- capivasertib
- Active ingredients
- Capivasertib — 160 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- AstraZeneca Pharmaceuticals LPNDC labeler code 0310
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 218197
- Marketing start
- Listing expires
- Identifiers
- Product ID 0310-9500_35bf673a-53ef-404c-bcdb-08fc92e7e46bSPL ID 35bf673a-53ef-404c-bcdb-08fc92e7e46b
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
N400310950001followed by a unit qualifier and the quantityPackage 00310-9500-01. 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 0310-9500
- What is NDC 0310-9500?
- 0310-9500 is the product NDC for Truqap (capivasertib), Capivasertib 160 mg/1 tablet, film coated, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Truqap (Capivasertib).
- What is the active ingredient?
- Capivasertib.
- Who is the labeler?
- AstraZeneca Pharmaceuticals LP, NDC labeler code 0310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Truqap?
- 1 other product NDC are listed under this name. See all Truqap NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Truqap products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Truqapcapivasertib | Capivasertib 200 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-9501 | 00310-9501-0100310-9501-0200310-9501-04+1 more |
Other NDCs under NDA 218197
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 |
|---|---|---|---|---|
| Truqapcapivasertib | Capivasertib 200 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-9501 |