eptifibatide

Generic: eptifibatide

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eptifibatide
Generic Name eptifibatide
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

eptifibatide 2 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 72078-027
Product ID 72078-027_7af20acf-ba9f-4387-9729-85d3c137f41e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203258
Listing Expiration 2026-12-31
Marketing Start 2021-04-01

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 72078027
Hyphenated Format 72078-027

Supplemental Identifiers

RxCUI
200349 1736470 1736477
UPC
0372078026108 0372078027105
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 ANDA203258 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (72078-027-10) / 100 mL in 1 VIAL
source: ndc

Packages (1)

72078-027-10 1 VIAL in 1 CARTON (72078-027-10) / 100 mL in 1 VIAL

Ingredients (1)

eptifibatide (2 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": "7af20acf-ba9f-4387-9729-85d3c137f41e", "openfda": {"nui": ["N0000008832", "N0000175578"], "upc": ["0372078026108", "0372078027105"], "unii": ["NA8320J834"], "rxcui": ["200349", "1736470", "1736477"], "spl_set_id": ["a7a89c59-22fb-41fd-b70a-ac2395717db1"], "pharm_class_pe": ["Decreased Platelet Aggregation [PE]"], "pharm_class_epc": ["Platelet Aggregation Inhibitor [EPC]"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (72078-027-10)  / 100 mL in 1 VIAL", "package_ndc": "72078-027-10", "marketing_start_date": "20210401"}], "brand_name": "Eptifibatide", "product_id": "72078-027_7af20acf-ba9f-4387-9729-85d3c137f41e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Decreased Platelet Aggregation [PE]", "Platelet Aggregation Inhibitor [EPC]"], "product_ndc": "72078-027", "generic_name": "eptifibatide", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eptifibatide", "active_ingredients": [{"name": "EPTIFIBATIDE", "strength": "2 mg/mL"}], "application_number": "ANDA203258", "marketing_category": "ANDA", "marketing_start_date": "20210401", "listing_expiration_date": "20261231"}