Prescription drug · NDA
Epinephrine NDC 76329-3318
Epinephrine .1 mg/mL · Injection · Intravenous · International Medication Systems, Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76329-3318-1 | 76329331801 | 10 CARTON in 1 PACKAGE (76329-3318-1) / 1 SYRINGE in 1 CARTON / 10 mL in 1 SYRINGEMarketed from Jan 30, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Epinephrine
- Generic name (nonproprietary)
- epinephrine
- Active ingredients
- Epinephrine — .1 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211363
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Catecholamines (Chemical structure)
- Identifiers
- Product ID 76329-3318_fde15adc-52e9-4f6e-8437-5a450934b280SPL ID fde15adc-52e9-4f6e-8437-5a450934b280SPL set ID f2b5f15b-8541-466a-a27a-ee57bc4aac67RxCUI 727373UNII YKH834O4BH
- Pharmacologic class
- Catecholamine; alpha-Adrenergic Agonist; beta-Adrenergic Agonist
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 codeMed-Code curated
J0171 — Injection, adrenalin, epinephrine, 0.1 mg
Billing unit: 0.1 mg. Units on the claim = dose given ÷ 0.1 mg.
Applies when epinephrine is administered in a clinical setting. Auto-injectors dispensed to patients are billed by NDC through a pharmacy benefit.
- 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
N476329331801followed by a unit qualifier and the quantityPackage 76329-3318-01. 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)
Epinephrine is a non-selective alpha and beta adrenergic agonist indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. ( 1.1 ) 1.1 Hypotension associated with Septic Shock Epinephrine Injection USP, 1 mg/10 mL (0.1 mg/mL) is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 211363
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 |
|---|---|---|---|---|
| Epinephrine | Epinephrine .1 mg/mL | InjectionIntravenous | REMEDYREPACK INC. | 70518-3816 |
| Epinephrine | Epinephrine .1 mg/mL | InjectionIntravenous | A-S Medication Solutions | 50090-7037 |
| Epinephrine | Epinephrine .1 mg/mL | InjectionIntravenous | ProPharma Distribution | 84549-018 |
| Epinephrine | Epinephrine .1 mg/mL | InjectionIntravenous | Henry Schein, Inc. | 0404-9806 |
| Epinephrine | Epinephrine .1 mg/mL | InjectionIntravenous | Medical Purchasing Solutions, LLC | 71872-7304 |
| Epinephrine | Epinephrine .1 mg/mL | InjectionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1629 |