0310-0512 : Calquence 100 mg Oral Capsule, Gelatin Coated

Labeler: Astrazeneca Pharmaceuticals Lp
Product Type: Human Prescription Drug
Drug Name:  Calquence
Dosage Form: Oral Capsule, Gelatin Coated
Application #: NDA210259
Rev. Date: 


Markings: ACA;100
Shapes:  Capsule
Colors:  Yellow
Size (mm): 1
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 0310-0512-28: 28 CAPSULE, GELATIN COATED IN 1 BOTTLE (0310‑0512‑28)
  • 0310-0512-60: 60 CAPSULE, GELATIN COATED IN 1 BOTTLE (0310‑0512‑60)
  • 0310-0512-95: 60 CAPSULE, GELATIN COATED IN 1 BOTTLE (0310‑0512‑95)

Active Ingredients:

  • Acalabrutinib

Dosage Strength:

  • 100 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Starch, Corn
  • Magnesium Stearate
  • Sodium Starch Glycolate Type a Potato
  • Gelatin
  • Titanium Dioxide
  • Ferric Oxide Yellow
  • Fd&c Blue No. 2
  • Silicon Dioxide

Pharmaceutical Classes:

  • Kinase Inhibitor [EPC]
  • Tyrosine Kinase Inhibitors [MoA]


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Note: The MedsChat® NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.