Package 0173-0915-13

Brand: zejula

Generic: niraparib
NDC Package

Package Facts

Identity

Package NDC 0173-0915-13
Digits Only 0173091513
Product NDC 0173-0915
Product ID 0173-0915_81e0aa4a-eae5-4749-9c77-6511c5d3dfd8
Description

30 TABLET, FILM COATED in 1 BOTTLE (0173-0915-13)

Marketing

Marketing Status
Marketed Since 2023-06-27
Brand zejula
Generic niraparib
Sample Package No

Linked Drug Pages (1)

ZEJULA ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "81e0aa4a-eae5-4749-9c77-6511c5d3dfd8", "openfda": {"upc": ["0301730909138", "0301730915139", "0301730912138"], "unii": ["195Q483UZD"], "rxcui": ["2637449", "2637452", "2637465", "2640210", "2640212", "2640214"], "spl_set_id": ["b7f675e2-159c-490c-b6f4-3f16d9492b7d"], "manufacturer_name": ["GlaxoSmithKline LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0173-0915-13)", "package_ndc": "0173-0915-13", "marketing_start_date": "20230627"}, {"sample": true, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0173-0915-61)", "package_ndc": "0173-0915-61", "marketing_start_date": "20230627"}], "brand_name": "ZEJULA", "product_id": "0173-0915_81e0aa4a-eae5-4749-9c77-6511c5d3dfd8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Poly(ADP-Ribose) Polymerase Inhibitor [EPC]", "Poly(ADP-Ribose) Polymerase Inhibitors [MoA]"], "product_ndc": "0173-0915", "generic_name": "niraparib", "labeler_name": "GlaxoSmithKline LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZEJULA", "active_ingredients": [{"name": "NIRAPARIB TOSYLATE", "strength": "300 mg/1"}], "application_number": "NDA214876", "marketing_category": "NDA", "marketing_start_date": "20230627", "listing_expiration_date": "20261231"}