eptifibatide

Generic: eptifibatide

Labeler: baxter healthcare company
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eptifibatide
Generic Name eptifibatide
Labeler baxter healthcare company
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

eptifibatide 75 mg/100mL

Manufacturer
Baxter Healthcare Company

Identifiers & Regulatory

Product NDC 0338-9558
Product ID 0338-9558_ef735fed-22fb-4b20-9b28-828f4610e367
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208554
Listing Expiration 2026-12-31
Marketing Start 2019-02-01

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 03389558
Hyphenated Format 0338-9558

Supplemental Identifiers

RxCUI
200349
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 ANDA208554 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 75 mg/100mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0338-9558-10) / 100 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0338-9558-10 1 VIAL, SINGLE-DOSE in 1 CARTON (0338-9558-10) / 100 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

eptifibatide (75 mg/100mL)

Linked Drug Pages (1)

Eptifibatide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ef735fed-22fb-4b20-9b28-828f4610e367", "openfda": {"nui": ["N0000008832", "N0000175578"], "unii": ["NA8320J834"], "rxcui": ["200349"], "spl_set_id": ["5f46b76b-5c83-49b9-ada8-4ad5cf81a38c"], "pharm_class_pe": ["Decreased Platelet Aggregation [PE]"], "pharm_class_epc": ["Platelet Aggregation Inhibitor [EPC]"], "manufacturer_name": ["Baxter Healthcare Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0338-9558-10)  / 100 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0338-9558-10", "marketing_start_date": "20190201"}], "brand_name": "Eptifibatide", "product_id": "0338-9558_ef735fed-22fb-4b20-9b28-828f4610e367", "dosage_form": "INJECTION", "pharm_class": ["Decreased Platelet Aggregation [PE]", "Platelet Aggregation Inhibitor [EPC]"], "product_ndc": "0338-9558", "generic_name": "Eptifibatide", "labeler_name": "Baxter Healthcare Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eptifibatide", "active_ingredients": [{"name": "EPTIFIBATIDE", "strength": "75 mg/100mL"}], "application_number": "ANDA208554", "marketing_category": "ANDA", "marketing_start_date": "20190201", "listing_expiration_date": "20261231"}