effient

Generic: prasugrel hydrochloride

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name effient
Generic Name prasugrel hydrochloride
Labeler cosette pharmaceuticals, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

prasugrel hydrochloride 5 mg/1

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0881
Product ID 0713-0881_e8172297-af81-4c37-e053-2995a90ad4e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022307
Listing Expiration 2026-12-31
Marketing Start 2022-09-01

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 07130881
Hyphenated Format 0713-0881

Supplemental Identifiers

RxCUI
855812 855816 855818 855820
UPC
0307130882309 0307130881302
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 effient (source: ndc)
Generic Name prasugrel hydrochloride (source: ndc)
Application Number NDA022307 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (0713-0881-30)
source: ndc

Packages (1)

0713-0881-30 30 TABLET, COATED in 1 BOTTLE (0713-0881-30)

Ingredients (1)

prasugrel hydrochloride (5 mg/1)

Linked Drug Pages (1)

Effient ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e8172297-af81-4c37-e053-2995a90ad4e5", "openfda": {"upc": ["0307130882309", "0307130881302"], "unii": ["G89JQ59I13"], "rxcui": ["855812", "855816", "855818", "855820"], "spl_set_id": ["69ea2d58-5353-4222-b61f-cab976fa7e5e"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (0713-0881-30)", "package_ndc": "0713-0881-30", "marketing_start_date": "20220901"}], "brand_name": "Effient", "product_id": "0713-0881_e8172297-af81-4c37-e053-2995a90ad4e5", "dosage_form": "TABLET, COATED", "pharm_class": ["Decreased Platelet Aggregation [PE]", "P2Y12 Platelet Inhibitor [EPC]", "P2Y12 Receptor Antagonists [MoA]"], "product_ndc": "0713-0881", "generic_name": "Prasugrel Hydrochloride", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Effient", "active_ingredients": [{"name": "PRASUGREL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "NDA022307", "marketing_category": "NDA", "marketing_start_date": "20220901", "listing_expiration_date": "20261231"}