Prescription drug · ANDA
Eptifibatide NDC 67457-631
Eptifibatide .75 mg/mL · Injection, Solution · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-631-10 | 67457063110 | 1 VIAL in 1 CARTON (67457-631-10) / 100 mL in 1 VIALMarketed from Dec 13, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Eptifibatide
- Generic name (nonproprietary)
- eptifibatide
- Active ingredients
- Eptifibatide — .75 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Mylan Institutional LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203258
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Platelet Aggregation (Physiologic effect)
- Identifiers
- Product ID 67457-631_e966c894-560e-4805-bdd5-16e153bb4687SPL ID e966c894-560e-4805-bdd5-16e153bb4687SPL set ID 88a37f9c-496b-4a6b-9665-4550abba04f1RxCUI 200349, 1736470, 1736477UNII NA8320J834UPC 0367457631103, 0367457630106, 0367457629100
- Pharmacologic class
- Platelet Aggregation Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N467457063110followed by a unit qualifier and the quantityPackage 67457-0631-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Eptifibatide injection is a platelet aggregation inhibitor indicated for: • Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) ( 1.1 ) • Treatment of patients undergoing PCI (including intracoronary stenting) ( 1.2 ) 1.1 Acute Coronary Syndrome (ACS) Eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (MI) in patients with ACS (unstable angina [UA]/non-ST- elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI). 1.2 Percutaneous Coronary Intervention (PCI) Eptifibatide i…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203258
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Eptifibatide | Eptifibatide 2 mg/mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-629 |
| Eptifibatide | Eptifibatide 2 mg/mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-630 |
| Eptifibatide | Eptifibatide .75 mg/mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 72078-026 |
| Eptifibatide | Eptifibatide 2 mg/mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 72078-025 |
| Eptifibatide | Eptifibatide 2 mg/mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 72078-027 |