prasugrel

Generic: prasugrel

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prasugrel
Generic Name prasugrel
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

prasugrel hydrochloride 10 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-002
Product ID 65162-002_ae5f7419-c5fe-4462-8f0e-ffc08e891cd0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205913
Listing Expiration 2026-12-31
Marketing Start 2018-06-22

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 65162002
Hyphenated Format 65162-002

Supplemental Identifiers

RxCUI
855812 855818
UPC
0365162002034 0365162001037
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 ANDA205913 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (65162-002-03)
source: ndc

Packages (1)

65162-002-03 30 TABLET, FILM COATED in 1 BOTTLE (65162-002-03)

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": "ae5f7419-c5fe-4462-8f0e-ffc08e891cd0", "openfda": {"upc": ["0365162002034", "0365162001037"], "unii": ["G89JQ59I13"], "rxcui": ["855812", "855818"], "spl_set_id": ["406cc201-89b6-43cc-9e14-a59327a5b4d8"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65162-002-03)", "package_ndc": "65162-002-03", "marketing_start_date": "20180622"}], "brand_name": "Prasugrel", "product_id": "65162-002_ae5f7419-c5fe-4462-8f0e-ffc08e891cd0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Platelet Aggregation [PE]", "P2Y12 Platelet Inhibitor [EPC]", "P2Y12 Receptor Antagonists [MoA]"], "product_ndc": "65162-002", "generic_name": "Prasugrel", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prasugrel", "active_ingredients": [{"name": "PRASUGREL HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA205913", "marketing_category": "ANDA", "marketing_start_date": "20180622", "listing_expiration_date": "20261231"}