prasugrel

Generic: prasugrel

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prasugrel
Generic Name prasugrel
Labeler apotex corp.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

prasugrel hydrochloride 10 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-4856
Product ID 60505-4856_2f6d84cf-47d7-4b76-e063-6294a90ac424
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205897
Listing Expiration 2026-12-31
Marketing Start 2025-02-15

Pharmacologic Class

Classes
decreased platelet aggregation [pe] p2y12 platelet inhibitor [epc] p2y12 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605054856
Hyphenated Format 60505-4856

Supplemental Identifiers

RxCUI
855812 855818
UPC
0360505464234 0360505485635 0360505464333
UNII
G89JQ59I13

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 prasugrel (source: ndc)
Generic Name prasugrel (source: ndc)
Application Number ANDA205897 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (60505-4856-3)
source: ndc

Packages (1)

60505-4856-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-4856-3)

Ingredients (1)

prasugrel hydrochloride (10 mg/1)

Linked Drug Pages (1)

PRASUGREL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2f6d84cf-47d7-4b76-e063-6294a90ac424", "openfda": {"upc": ["0360505464234", "0360505485635", "0360505464333"], "unii": ["G89JQ59I13"], "rxcui": ["855812", "855818"], "spl_set_id": ["f51e64e0-f556-65d0-a876-fb709aaeefea"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (60505-4856-3)", "package_ndc": "60505-4856-3", "marketing_start_date": "20250215"}], "brand_name": "PRASUGREL", "product_id": "60505-4856_2f6d84cf-47d7-4b76-e063-6294a90ac424", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Platelet Aggregation [PE]", "P2Y12 Platelet Inhibitor [EPC]", "P2Y12 Receptor Antagonists [MoA]"], "product_ndc": "60505-4856", "generic_name": "PRASUGREL", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PRASUGREL", "active_ingredients": [{"name": "PRASUGREL HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA205897", "marketing_category": "ANDA", "marketing_start_date": "20250215", "listing_expiration_date": "20261231"}