eptifibatide

Generic: eptifibatide

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

Drug Facts

Product Profile

Brand Name eptifibatide
Generic Name eptifibatide
Labeler avenacy inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

eptifibatide .75 mg/mL

Manufacturer
Avenacy Inc.

Identifiers & Regulatory

Product NDC 83634-301
Product ID 83634-301_74e580c1-7f30-49cf-8e83-968bc05c5559
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213081
Listing Expiration 2026-12-31
Marketing Start 2024-01-31

Pharmacologic Class

Established (EPC)
platelet aggregation inhibitor [epc]
Physiologic Effect
decreased platelet aggregation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83634301
Hyphenated Format 83634-301

Supplemental Identifiers

RxCUI
200349 1736470
UNII
NA8320J834
NUI
N0000008832 N0000175578

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 eptifibatide (source: ndc)
Generic Name eptifibatide (source: ndc)
Application Number ANDA213081 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .75 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (83634-301-51) / 100 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

83634-301-51 1 VIAL, SINGLE-DOSE in 1 CARTON (83634-301-51) / 100 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

eptifibatide (.75 mg/mL)

Linked Drug Pages (1)

Eptifibatide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "74e580c1-7f30-49cf-8e83-968bc05c5559", "openfda": {"nui": ["N0000008832", "N0000175578"], "unii": ["NA8320J834"], "rxcui": ["200349", "1736470"], "spl_set_id": ["c0781dae-3ef6-4cab-b084-01d2e45f3764"], "pharm_class_pe": ["Decreased Platelet Aggregation [PE]"], "pharm_class_epc": ["Platelet Aggregation Inhibitor [EPC]"], "manufacturer_name": ["Avenacy Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (83634-301-51)  / 100 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "83634-301-51", "marketing_start_date": "20240131"}], "brand_name": "Eptifibatide", "product_id": "83634-301_74e580c1-7f30-49cf-8e83-968bc05c5559", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Decreased Platelet Aggregation [PE]", "Platelet Aggregation Inhibitor [EPC]"], "product_ndc": "83634-301", "generic_name": "eptifibatide", "labeler_name": "Avenacy Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eptifibatide", "active_ingredients": [{"name": "EPTIFIBATIDE", "strength": ".75 mg/mL"}], "application_number": "ANDA213081", "marketing_category": "ANDA", "marketing_start_date": "20240131", "listing_expiration_date": "20261231"}