vizimpro

Generic: dacomitinib

Labeler: u.s. pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vizimpro
Generic Name dacomitinib
Labeler u.s. pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

dacomitinib 15 mg/1

Manufacturer
U.S. Pharmaceuticals

Identifiers & Regulatory

Product NDC 63539-197
Product ID 63539-197_b0b607d1-7a3d-40a2-bf2e-b7eb0f00f762
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211288
Listing Expiration 2026-12-31
Marketing Start 2019-02-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63539197
Hyphenated Format 63539-197

Supplemental Identifiers

RxCUI
2058915 2058922
UNII
5092U85G58

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 vizimpro (source: ndc)
Generic Name dacomitinib (source: ndc)
Application Number NDA211288 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63539-197-90)
source: ndc

Packages (1)

63539-197-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63539-197-90)

Ingredients (1)

dacomitinib (15 mg/1)

Linked Drug Pages (1)

Vizimpro ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b0b607d1-7a3d-40a2-bf2e-b7eb0f00f762", "openfda": {"unii": ["5092U85G58"], "rxcui": ["2058915", "2058922"], "spl_set_id": ["90da33c1-5689-4b4d-a2b5-377e1057a843"], "manufacturer_name": ["U.S. Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63539-197-90)", "package_ndc": "63539-197-90", "marketing_start_date": "20190201"}], "brand_name": "Vizimpro", "product_id": "63539-197_b0b607d1-7a3d-40a2-bf2e-b7eb0f00f762", "dosage_form": "TABLET, FILM COATED", "product_ndc": "63539-197", "generic_name": "dacomitinib", "labeler_name": "U.S. Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vizimpro", "active_ingredients": [{"name": "DACOMITINIB", "strength": "15 mg/1"}], "application_number": "NDA211288", "marketing_category": "NDA", "marketing_start_date": "20190201", "listing_expiration_date": "20261231"}