Prescription drug · NDA
Calquence (Acalabrutinib) NDC 0310-0512
Acalabrutinib 100 mg/1 · Capsule, Gelatin coated · Oral · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Calquence
- Generic name (nonproprietary)
- acalabrutinib
- Active ingredients
- Acalabrutinib — 100 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- AstraZeneca Pharmaceuticals LPNDC labeler code 0310
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210259
- Marketing start
- Listing expires
- Other FDA classes
- Tyrosine Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 0310-0512_aa4e8627-21c7-413a-9d0d-1957ded93283SPL ID aa4e8627-21c7-413a-9d0d-1957ded93283SPL set ID dd4835ef-e1bc-4997-a399-1ffa2556fbfeRxCUI 1986813, 1986819UNII 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.
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) …
Excerpt only. Read the full label for complete information.
About NDC 0310-0512
- What is NDC 0310-0512?
- 0310-0512 is the product NDC for Calquence (acalabrutinib), Acalabrutinib 100 mg/1 capsule, gelatin coated, listed with the FDA by AstraZeneca Pharmaceuticals LP.
- 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 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-4513 | 00310-4513-60 |