prasugrel

Generic: prasugrel

Labeler: panacea biotec limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

prasugrel hydrochloride 10 mg/1

Manufacturer
Panacea Biotec Limited

Identifiers & Regulatory

Product NDC 43817-240
Product ID 43817-240_2de10117-c50f-95af-e063-6294a90ab07d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205897
Marketing Start 2017-10-16
Marketing End 2026-10-31

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 43817240
Hyphenated Format 43817-240

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 ANDA205897 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (43817-240-01)
source: ndc

Packages (1)

43817-240-01 30 TABLET, FILM COATED in 1 BOTTLE (43817-240-01)

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": "2de10117-c50f-95af-e063-6294a90ab07d", "openfda": {"unii": ["G89JQ59I13"], "rxcui": ["855812", "855818"], "spl_set_id": ["944c195a-de24-a44c-8baa-84b624b5ddcb"], "manufacturer_name": ["Panacea Biotec Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (43817-240-01)", "package_ndc": "43817-240-01", "marketing_end_date": "20261031", "marketing_start_date": "20171016"}], "brand_name": "PRASUGREL", "product_id": "43817-240_2de10117-c50f-95af-e063-6294a90ab07d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Platelet Aggregation [PE]", "P2Y12 Platelet Inhibitor [EPC]", "P2Y12 Receptor Antagonists [MoA]"], "product_ndc": "43817-240", "generic_name": "PRASUGREL", "labeler_name": "Panacea Biotec Limited", "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_end_date": "20261031", "marketing_start_date": "20171016"}