eptifibatide

Generic: eptifibatide

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

Drug Facts

Product Profile

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

eptifibatide 2 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-412
Product ID 71288-412_a15dafa6-7923-4999-8938-28e580304e57
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213599
Listing Expiration 2026-12-31
Marketing Start 2024-05-09

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 71288412
Hyphenated Format 71288-412

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 ANDA213599 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-412-10) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

71288-412-10 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-412-10) / 10 mL in 1 VIAL, SINGLE-DOSE

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": "a15dafa6-7923-4999-8938-28e580304e57", "openfda": {"nui": ["N0000008832", "N0000175578"], "unii": ["NA8320J834"], "rxcui": ["200349", "1736470"], "spl_set_id": ["3e7e7cd3-8efa-4d91-a5ab-7fd78b0cc65e"], "pharm_class_pe": ["Decreased Platelet Aggregation [PE]"], "pharm_class_epc": ["Platelet Aggregation Inhibitor [EPC]"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-412-10)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-412-10", "marketing_start_date": "20240509"}], "brand_name": "Eptifibatide", "product_id": "71288-412_a15dafa6-7923-4999-8938-28e580304e57", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Decreased Platelet Aggregation [PE]", "Platelet Aggregation Inhibitor [EPC]"], "product_ndc": "71288-412", "generic_name": "Eptifibatide", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eptifibatide", "active_ingredients": [{"name": "EPTIFIBATIDE", "strength": "2 mg/mL"}], "application_number": "ANDA213599", "marketing_category": "ANDA", "marketing_start_date": "20240509", "listing_expiration_date": "20261231"}