eptifibatide

Generic: eptifibatide

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eptifibatide
Generic Name eptifibatide
Labeler eugia us llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

eptifibatide 20 mg/10mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-219
Product ID 55150-219_944b269c-d810-411d-9ed4-8edd9d0ac1b7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206127
Listing Expiration 2026-12-31
Marketing Start 2015-12-08

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 55150219
Hyphenated Format 55150-219

Supplemental Identifiers

RxCUI
200349 1736470 1736477
UPC
0355150220991 0355150219100
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 ANDA206127 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-219-10) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-219-10 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-219-10) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

eptifibatide (20 mg/10mL)

Linked Drug Pages (1)

Eptifibatide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "944b269c-d810-411d-9ed4-8edd9d0ac1b7", "openfda": {"nui": ["N0000008832", "N0000175578"], "upc": ["0355150220991", "0355150219100"], "unii": ["NA8320J834"], "rxcui": ["200349", "1736470", "1736477"], "spl_set_id": ["00ad7bbe-cadd-4647-b74b-adfc9f2b5e94"], "pharm_class_pe": ["Decreased Platelet Aggregation [PE]"], "pharm_class_epc": ["Platelet Aggregation Inhibitor [EPC]"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55150-219-10)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-219-10", "marketing_start_date": "20151208"}], "brand_name": "Eptifibatide", "product_id": "55150-219_944b269c-d810-411d-9ed4-8edd9d0ac1b7", "dosage_form": "INJECTION", "pharm_class": ["Decreased Platelet Aggregation [PE]", "Platelet Aggregation Inhibitor [EPC]"], "product_ndc": "55150-219", "generic_name": "Eptifibatide", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eptifibatide", "active_ingredients": [{"name": "EPTIFIBATIDE", "strength": "20 mg/10mL"}], "application_number": "ANDA206127", "marketing_category": "ANDA", "marketing_start_date": "20151208", "listing_expiration_date": "20261231"}