calquence

Generic: acalabrutinib

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name calquence
Generic Name acalabrutinib
Labeler astrazeneca pharmaceuticals lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acalabrutinib 100 mg/1

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-3512
Product ID 0310-3512_7365aa18-60da-4ce6-9c06-01c80e158286
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216387
Listing Expiration 2027-12-31
Marketing Start 2022-08-04

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
tyrosine kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03103512
Hyphenated Format 0310-3512

Supplemental Identifiers

RxCUI
2607734 2607737
UNII
I42748ELQW
NUI
N0000175605 N0000020001

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name calquence (source: ndc)
Generic Name acalabrutinib (source: ndc)
Application Number NDA216387 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (0310-3512-60)
  • 60 TABLET, FILM COATED in 1 BLISTER PACK (0310-3512-95)
source: ndc

Packages (2)

0310-3512-60 60 TABLET, FILM COATED in 1 BOTTLE (0310-3512-60) 0310-3512-95 60 TABLET, FILM COATED in 1 BLISTER PACK (0310-3512-95)

Ingredients (1)

acalabrutinib (100 mg/1)

Linked Drug Pages (1)

CALQUENCE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7365aa18-60da-4ce6-9c06-01c80e158286", "openfda": {"nui": ["N0000175605", "N0000020001"], "unii": ["I42748ELQW"], "rxcui": ["2607734", "2607737"], "spl_set_id": ["b1409184-3267-4d8c-8f17-4e01f69828b1"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Tyrosine Kinase Inhibitors [MoA]"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (0310-3512-60)", "package_ndc": "0310-3512-60", "marketing_start_date": "20220804"}, {"sample": true, "description": "60 TABLET, FILM COATED in 1 BLISTER PACK (0310-3512-95)", "package_ndc": "0310-3512-95", "marketing_start_date": "20220804"}], "brand_name": "CALQUENCE", "product_id": "0310-3512_7365aa18-60da-4ce6-9c06-01c80e158286", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Tyrosine Kinase Inhibitors [MoA]"], "product_ndc": "0310-3512", "generic_name": "acalabrutinib", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CALQUENCE", "active_ingredients": [{"name": "ACALABRUTINIB", "strength": "100 mg/1"}], "application_number": "NDA216387", "marketing_category": "NDA", "marketing_start_date": "20220804", "listing_expiration_date": "20271231"}