prasugrel

Generic: prasugrel

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prasugrel
Generic Name prasugrel
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

prasugrel hydrochloride 5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-829
Product ID 65862-829_ad62076d-f75e-4cfa-b68f-3e873f244bcb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205888
Listing Expiration 2026-12-31
Marketing Start 2017-10-16

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 65862829
Hyphenated Format 65862-829

Supplemental Identifiers

RxCUI
855812 855818
UPC
0365862830302 0365862829306
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 ANDA205888 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (65862-829-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-829-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-829-30)
source: ndc

Packages (2)

65862-829-03 3 BLISTER PACK in 1 CARTON (65862-829-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-829-10) 65862-829-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-829-30)

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": "ad62076d-f75e-4cfa-b68f-3e873f244bcb", "openfda": {"upc": ["0365862830302", "0365862829306"], "unii": ["G89JQ59I13"], "rxcui": ["855812", "855818"], "spl_set_id": ["596c923d-db8d-4b96-bf31-52186a38c30d"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (65862-829-03)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-829-10)", "package_ndc": "65862-829-03", "marketing_start_date": "20171016"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-829-30)", "package_ndc": "65862-829-30", "marketing_start_date": "20171016"}], "brand_name": "Prasugrel", "product_id": "65862-829_ad62076d-f75e-4cfa-b68f-3e873f244bcb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Platelet Aggregation [PE]", "P2Y12 Platelet Inhibitor [EPC]", "P2Y12 Receptor Antagonists [MoA]"], "product_ndc": "65862-829", "generic_name": "Prasugrel", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prasugrel", "active_ingredients": [{"name": "PRASUGREL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA205888", "marketing_category": "ANDA", "marketing_start_date": "20171016", "listing_expiration_date": "20261231"}