zejula

Generic: niraparib

Labeler: glaxosmithkline llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zejula
Generic Name niraparib
Labeler glaxosmithkline llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

niraparib tosylate 200 mg/1

Manufacturer
GlaxoSmithKline LLC

Identifiers & Regulatory

Product NDC 0173-0912
Product ID 0173-0912_81e0aa4a-eae5-4749-9c77-6511c5d3dfd8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214876
Listing Expiration 2026-12-31
Marketing Start 2023-06-27

Pharmacologic Class

Classes
poly(adp-ribose) polymerase inhibitor [epc] poly(adp-ribose) polymerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01730912
Hyphenated Format 0173-0912

Supplemental Identifiers

RxCUI
2637449 2637452 2637465 2640210 2640212 2640214
UPC
0301730909138 0301730915139 0301730912138
UNII
195Q483UZD

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 zejula (source: ndc)
Generic Name niraparib (source: ndc)
Application Number NDA214876 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0173-0912-13)
  • 30 TABLET, FILM COATED in 1 BOTTLE (0173-0912-61)
source: ndc

Packages (2)

0173-0912-13 30 TABLET, FILM COATED in 1 BOTTLE (0173-0912-13) 0173-0912-61 30 TABLET, FILM COATED in 1 BOTTLE (0173-0912-61)

Ingredients (1)

niraparib tosylate (200 mg/1)

Linked Drug Pages (1)

ZEJULA ndc-match (0.9)

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 (0173-0912-13)", "package_ndc": "0173-0912-13", "marketing_start_date": "20230627"}, {"sample": true, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0173-0912-61)", "package_ndc": "0173-0912-61", "marketing_start_date": "20230627"}], "brand_name": "ZEJULA", "product_id": "0173-0912_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": "0173-0912", "generic_name": "niraparib", "labeler_name": "GlaxoSmithKline LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZEJULA", "active_ingredients": [{"name": "NIRAPARIB TOSYLATE", "strength": "200 mg/1"}], "application_number": "NDA214876", "marketing_category": "NDA", "marketing_start_date": "20230627", "listing_expiration_date": "20261231"}