prasugrel

Generic: prasugrel

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prasugrel
Generic Name prasugrel
Labeler accord healthcare inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

prasugrel hydrochloride 5 mg/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-272
Product ID 16729-272_0e2f030a-d262-a36c-e063-6294a90a40ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205987
Listing Expiration 2026-12-31
Marketing Start 2019-01-16

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 16729272
Hyphenated Format 16729-272

Supplemental Identifiers

RxCUI
855812 855818
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 ANDA205987 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (16729-272-10)
source: ndc

Packages (1)

16729-272-10 30 TABLET, FILM COATED in 1 BOTTLE (16729-272-10)

Ingredients (1)

prasugrel hydrochloride (5 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": "0e2f030a-d262-a36c-e063-6294a90a40ef", "openfda": {"unii": ["G89JQ59I13"], "rxcui": ["855812", "855818"], "spl_set_id": ["cd6bf899-06b7-4f52-96c5-ffc94a7288ff"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (16729-272-10)", "package_ndc": "16729-272-10", "marketing_start_date": "20190116"}], "brand_name": "Prasugrel", "product_id": "16729-272_0e2f030a-d262-a36c-e063-6294a90a40ef", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Platelet Aggregation [PE]", "P2Y12 Platelet Inhibitor [EPC]", "P2Y12 Receptor Antagonists [MoA]"], "product_ndc": "16729-272", "generic_name": "Prasugrel", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prasugrel", "active_ingredients": [{"name": "PRASUGREL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA205987", "marketing_category": "ANDA", "marketing_start_date": "20190116", "listing_expiration_date": "20261231"}