Calquence (acalabrutinib) NDC 0310-3512

NDC codes

FDA NDC Directory

Product NDC (as listed)0310-3512Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00310-3512Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0310-3512-60	00310351260	60 TABLET, FILM COATED in 1 BOTTLE (0310-3512-60)Marketed from Aug 4, 2022
0310-3512-95	00310351295	60 TABLET, FILM COATED in 1 BLISTER PACK (0310-3512-95)Marketed from Aug 4, 2022 · Sample package

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 LP
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 216387
Marketing start: Aug 4, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Tyrosine Kinase Inhibitors (Mechanism)
Identifiers: Product ID 0310-3512_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

N400310351260 followed by a unit qualifier and the quantity

Package 00310-3512-60. 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 Feb 19, 2026.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 216387

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 216387
Product	Strength	Form · route	Labeler	Product NDC
Calquenceacalabrutinib	Acalabrutinib 100 mg/1	Tablet, Film coatedOral	AstraZeneca Pharmaceuticals LP	0310-4513