eptifibatide

Generic: eptifibatide

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eptifibatide
Generic Name eptifibatide
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

eptifibatide .75 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-408
Product ID 25021-408_7e4a3720-9c2e-4fb7-b703-f896f7fd0686
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204693
Listing Expiration 2026-12-31
Marketing Start 2018-07-15

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 25021408
Hyphenated Format 25021-408

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 ANDA204693 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .75 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (25021-408-51) / 100 mL in 1 VIAL
source: ndc

Packages (1)

Ingredients (1)

eptifibatide (.75 mg/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "7e4a3720-9c2e-4fb7-b703-f896f7fd0686", "openfda": {"nui": ["N0000008832", "N0000175578"], "unii": ["NA8320J834"], "rxcui": ["200349", "1736470"], "spl_set_id": ["a0d18778-0194-461a-a4ea-b2fca5df57c3"], "pharm_class_pe": ["Decreased Platelet Aggregation [PE]"], "pharm_class_epc": ["Platelet Aggregation Inhibitor [EPC]"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (25021-408-51)  / 100 mL in 1 VIAL", "package_ndc": "25021-408-51", "marketing_start_date": "20180715"}], "brand_name": "eptifibatide", "product_id": "25021-408_7e4a3720-9c2e-4fb7-b703-f896f7fd0686", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Decreased Platelet Aggregation [PE]", "Platelet Aggregation Inhibitor [EPC]"], "product_ndc": "25021-408", "generic_name": "eptifibatide", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "eptifibatide", "active_ingredients": [{"name": "EPTIFIBATIDE", "strength": ".75 mg/mL"}], "application_number": "ANDA204693", "marketing_category": "ANDA", "marketing_start_date": "20180715", "listing_expiration_date": "20261231"}