NDC product

CALQUENCE

NDC 0310-0512 · AstraZeneca Pharmaceuticals LP

Key facts

Product NDC 0310-0512
Proprietary name CALQUENCE
Nonproprietary name Acalabrutinib
Substances ACALABRUTINIB
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler AstraZeneca Pharmaceuticals LP
Product type HUMAN PRESCRIPTION DRUG
Marketing category NDA
Application number NDA210259
Pharmacologic classes Kinase Inhibitor [EPC], Tyrosine Kinase Inhibitors [MoA]
Marketing start Oct 31, 2017
Listing certified through Dec 31, 2027

At a glance

  • 1–9 Package NDCs

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About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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