Package 0310-4513-60

Brand: calquence

Generic: acalabrutinib
NDC Package

Package Facts

Identity

Package NDC 0310-4513-60
Digits Only 0310451360
Product NDC 0310-4513
Product ID 0310-4513_7365aa18-60da-4ce6-9c06-01c80e158286
Description

60 TABLET, FILM COATED in 1 BOTTLE (0310-4513-60)

Marketing

Marketing Status
Marketed Since 2025-02-19
Brand calquence
Generic acalabrutinib
Sample Package No

Linked Drug Pages (1)

CALQUENCE ndc-match (0.95)

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 (0310-4513-60)", "package_ndc": "0310-4513-60", "marketing_start_date": "20250219"}], "brand_name": "CALQUENCE", "product_id": "0310-4513_7365aa18-60da-4ce6-9c06-01c80e158286", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Tyrosine Kinase Inhibitors [MoA]"], "product_ndc": "0310-4513", "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"}