Eptifibatide Injection
NDC Package 0338-9558-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Eptifibatide injection is treatment with eptifibatide is contraindicated in patients with: •A history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days•Severe hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >110 mm Hg) not adequately controlled on antihypertensive therapy•Major surgery within the preceding 6 weeks•History of stroke within 30 days or any history of hemorrhagic stroke•Current or planned administration of another parenteral GP IIb/IIIa inhibitor•Dependency on renal dialysis•Hypersensitivity to eptifibatide or any component of the product (hypersensitivity reactions that occurred included anaphylaxis and urticaria). This formulation utilizes a injection delivery system. Marketed by Baxter Healthcare Company, this product is identified by NDC 0338-9558 and is authorized under FDA application ANDA208554.

Identification & Billing

NDC Package Code
0338-9558-10
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 100 mL in 1 VIAL, SINGLE-DOSE
Product Code
0338-9558
11-Digit Billing Format
00338955810
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Eptifibatide
Non-Proprietary Name
Eptifibatide
Substance Name
Eptifibatide
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
EPTIFIBATIDE 75 mg/100mL
Pharmacologic Class
Usage Information
Treatment with eptifibatide is contraindicated in patients with: •A history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days•Severe hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >110 mm Hg) not adequately controlled on antihypertensive therapy•Major surgery within the preceding 6 weeks•History of stroke within 30 days or any history of hemorrhagic stroke•Current or planned administration of another parenteral GP IIb/IIIa inhibitor•Dependency on renal dialysis•Hypersensitivity to eptifibatide or any component of the product (hypersensitivity reactions that occurred included anaphylaxis and urticaria).

Regulatory & Marketing

Labeler Name
Baxter Healthcare Company
Product Type
Human Prescription Drug
FDA Application #
ANDA208554
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-01-2019
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1327
Source: OPPS
Eptifibatide injection
HCPCS Dosage 5 MG
Units / Pkg 180

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0338-9558-10 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 100 ml in 1 vial, single-dose of Eptifibatide, a human prescription drug labeled by Baxter Healthcare Company. This injection is formulated for intravenous use and contains eptifibatide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Baxter Healthcare Company on February 01, 2019. The current certification is valid through December 31, 2027.

How is this Baxter Healthcare Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338955810. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0338-9558-10
11-Digit CMS (5-4-2)
00338-9558-10

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.