cathflo activase

Generic: alteplase

Labeler: genentech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name cathflo activase
Generic Name alteplase
Labeler genentech, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

alteplase 2.2 mg/2mL

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-041
Product ID 50242-041_0c2938dd-2978-411f-bd76-208fc8754838
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103172
Listing Expiration 2027-12-31
Marketing Start 2001-09-04

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50242041
Hyphenated Format 50242-041

Supplemental Identifiers

UNII
1RXS4UE564

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 cathflo activase (source: ndc)
Generic Name alteplase (source: ndc)
Application Number BLA103172 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2.2 mg/2mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (50242-041-10) / 2 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (50242-041-64) / 2 mL in 1 VIAL
source: ndc

Packages (2)

50242-041-10 10 VIAL in 1 CARTON (50242-041-10) / 2 mL in 1 VIAL 50242-041-64 1 VIAL in 1 CARTON (50242-041-64) / 2 mL in 1 VIAL

Ingredients (1)

alteplase (2.2 mg/2mL)

Linked Drug Pages (1)

Cathflo Activase ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "0c2938dd-2978-411f-bd76-208fc8754838", "openfda": {"unii": ["1RXS4UE564"], "spl_set_id": ["91ecdef2-95ff-42dd-a31c-c8a09cab3ad9"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (50242-041-10)  / 2 mL in 1 VIAL", "package_ndc": "50242-041-10", "marketing_start_date": "20191014"}, {"sample": false, "description": "1 VIAL in 1 CARTON (50242-041-64)  / 2 mL in 1 VIAL", "package_ndc": "50242-041-64", "marketing_start_date": "20010904"}], "brand_name": "Cathflo Activase", "product_id": "50242-041_0c2938dd-2978-411f-bd76-208fc8754838", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "product_ndc": "50242-041", "generic_name": "Alteplase", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cathflo Activase", "active_ingredients": [{"name": "ALTEPLASE", "strength": "2.2 mg/2mL"}], "application_number": "BLA103172", "marketing_category": "BLA", "marketing_start_date": "20010904", "listing_expiration_date": "20271231"}