Package 0310-3512-95
Brand: calquence
Generic: acalabrutinibPackage Facts
Identity
Package NDC
0310-3512-95
Digits Only
0310351295
Product NDC
0310-3512
Description
60 TABLET, FILM COATED in 1 BLISTER PACK (0310-3512-95)
Marketing
Marketing Status
Brand
calquence
Generic
acalabrutinib
Sample Package
Yes
Linked Drug Pages (1)
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"}