prasugrel

Generic: prasugrel

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

prasugrel hydrochloride 10 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-5186
Product ID 0378-5186_9e234352-49b7-46e3-bc59-acf63e0a7a14
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205927
Listing Expiration 2026-12-31
Marketing Start 2017-08-15

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 03785186
Hyphenated Format 0378-5186

Supplemental Identifiers

RxCUI
855812 855818
UPC
0303785185932
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 ANDA205927 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5186-93)
source: ndc

Packages (1)

0378-5186-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5186-93)

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": "9e234352-49b7-46e3-bc59-acf63e0a7a14", "openfda": {"upc": ["0303785185932"], "unii": ["G89JQ59I13"], "rxcui": ["855812", "855818"], "spl_set_id": ["41a4e332-6725-4cb7-940a-8291cf56cfe4"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5186-93)", "package_ndc": "0378-5186-93", "marketing_start_date": "20170815"}], "brand_name": "Prasugrel", "product_id": "0378-5186_9e234352-49b7-46e3-bc59-acf63e0a7a14", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Platelet Aggregation [PE]", "P2Y12 Platelet Inhibitor [EPC]", "P2Y12 Receptor Antagonists [MoA]"], "product_ndc": "0378-5186", "generic_name": "Prasugrel", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prasugrel", "active_ingredients": [{"name": "PRASUGREL HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA205927", "marketing_category": "ANDA", "marketing_start_date": "20170815", "listing_expiration_date": "20261231"}