Prescription drug · ANDA
Eptifibatide NDC 0338-9558
Eptifibatide 75 mg/100mL · Injection · Intravenous · Baxter Healthcare Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-9558-10 | 0033895581000338955810 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0338-9558-10) / 100 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 1, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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/100mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Baxter Healthcare CompanyNDC labeler code 0338
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208554
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Platelet Aggregation (Physiologic effect)
- Identifiers
- Product ID 0338-9558_a90f397a-95b8-421c-9e34-b327671f97a3SPL ID a90f397a-95b8-421c-9e34-b327671f97a3SPL set ID 5f46b76b-5c83-49b9-ada8-4ad5cf81a38cRxCUI 200349UNII NA8320J834
- 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
N400338955810followed by a unit qualifier and the quantityPackage 00338-9558-10. 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 inject…
Excerpt only. Read the full label for complete information.
About NDC 0338-9558
- What is NDC 0338-9558?
- 0338-9558 is the product NDC for Eptifibatide, Eptifibatide 75 mg/100mL injection, listed with the FDA by Baxter Healthcare Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Eptifibatide.
- What is the active ingredient?
- Eptifibatide.
- Who is the labeler?
- Baxter Healthcare Company, NDC labeler code 0338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Eptifibatide?
- 20 other product NDCs are listed under this name. See all Eptifibatide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Eptifibatide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Eptifibatide | Eptifibatide 2 mg/mL | Injection, SolutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-412 | 71288-0412-10 |
| Eptifibatide | Eptifibatide .75 mg/mL | Injection, SolutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-413 | 71288-0413-51 |
| Eptifibatide | Eptifibatide 2 mg/mL | Injection, SolutionIntravenous | Avenacy, LLC | 83634-300 | 83634-0300-10 |
| Eptifibatide | Eptifibatide .75 mg/mL | Injection, SolutionIntravenous | Avenacy, LLC | 83634-301 | 83634-0301-51 |
| Eptifibatide | Eptifibatide .75 mg/mL | Injection, SolutionIntravenous | Hainan Shuangcheng Pharmaceuticals Co., Ltd. | 52958-040 | 52958-0040-01 |
| Eptifibatide | Eptifibatide 2 mg/mL | Injection, SolutionIntravenous | Hainan Shuangcheng Pharmaceuticals Co., Ltd. | 52958-402 | 52958-0402-01 |
| Eptifibatide | Eptifibatide 2 mg/mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 72078-025 | 72078-0025-10 |
| Eptifibatide | Eptifibatide 2 mg/mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 72078-027 | 72078-0027-10 |
| Eptifibatide | Eptifibatide .75 mg/mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 72078-026 | 72078-0026-10 |
| Eptifibatide | Eptifibatide 2 mg/mL | InjectionIntravenous | Slate Run Pharmaceuticals, LLC | 70436-026 | 70436-0026-80 |