Prescription drug · NDA
Calquence (Acalabrutinib) NDC 0310-4513
Acalabrutinib 100 mg/1 · Tablet, Film coated · Oral · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0310-4513-60 | 0031045136000310451360 | 60 TABLET, FILM COATED in 1 BOTTLE (0310-4513-60)Marketed from Feb 19, 2025 |
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)
- Calquence
- Generic name (nonproprietary)
- acalabrutinib
- Active ingredients
- Acalabrutinib — 100 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 216387
- Marketing start
- Listing expires
- Other FDA classes
- Tyrosine Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 0310-4513_7365aa18-60da-4ce6-9c06-01c80e158286SPL ID 7365aa18-60da-4ce6-9c06-01c80e158286SPL set ID b1409184-3267-4d8c-8f17-4e01f69828b1RxCUI 2607734, 2607737UNII I42748ELQW
- 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
N400310451360followed by a unit qualifier and the quantityPackage 00310-4513-60. 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 .
Indications (excerpt from the label)
CALQUENCE is a kinase inhibitor indicated: • In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). (1.1 ) • For the treatment of adult patients with MCL who have received at least one prior therapy. ( 1.2 ) • For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.3 ) 1.1 Previously Untreated Mantle Cell Lymphoma CALQUENCE in combination with bendamustine and rituximab is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) w…
Excerpt only. Read the full label for complete information.
About NDC 0310-4513
- What is NDC 0310-4513?
- 0310-4513 is the product NDC for Calquence (acalabrutinib), Acalabrutinib 100 mg/1 tablet, film coated, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Calquence (Acalabrutinib).
- What is the active ingredient?
- Acalabrutinib.
- 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 Calquence?
- 2 other product NDCs are listed under this name. See all Calquence NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Calquence products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Calquenceacalabrutinib | Acalabrutinib 100 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-3512 | 00310-3512-6000310-3512-95 |
| Calquenceacalabrutinib | Acalabrutinib 100 mg/1 | Capsule, Gelatin coatedOral | AstraZeneca Pharmaceuticals LP | 0310-0512 | — |
Other NDCs under NDA 216387
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 |
|---|---|---|---|---|
| Calquenceacalabrutinib | Acalabrutinib 100 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-3512 |