activase

Generic: alteplase

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

Drug Facts

Product Profile

Brand Name activase
Generic Name alteplase
Labeler genentech, inc.
Dosage Form KIT
Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-085
Product ID 50242-085_48ed2eb6-728a-41d8-b024-6b34e75dc4dc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103172
Listing Expiration 2027-12-31
Marketing Start 1987-11-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50242085
Hyphenated Format 50242-085

Supplemental Identifiers

RxCUI
1804799 1804802 1804804 1804806

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

Resolved Composition

Strengths
  • 50 mg
  • 50 ml
  • 100 mg
  • 100 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (50242-085-27) * 100 mL in 1 VIAL, SINGLE-USE * 100 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

50242-085-27 1 KIT in 1 CARTON (50242-085-27) * 100 mL in 1 VIAL, SINGLE-USE * 100 mL in 1 VIAL, SINGLE-USE

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Activase ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "48ed2eb6-728a-41d8-b024-6b34e75dc4dc", "openfda": {"rxcui": ["1804799", "1804802", "1804804", "1804806"], "spl_set_id": ["c669f77c-fa48-478b-a14b-80b20a0139c2"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (50242-085-27)  *  100 mL in 1 VIAL, SINGLE-USE *  100 mL in 1 VIAL, SINGLE-USE", "package_ndc": "50242-085-27", "marketing_start_date": "19871113"}], "brand_name": "Activase", "product_id": "50242-085_48ed2eb6-728a-41d8-b024-6b34e75dc4dc", "dosage_form": "KIT", "product_ndc": "50242-085", "generic_name": "Alteplase", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Activase", "application_number": "BLA103172", "marketing_category": "BLA", "marketing_start_date": "19871113", "listing_expiration_date": "20271231"}