Prescription drug · NDA
Epipen (Epinephrine) NDC 76420-584
Epinephrine .3 mg/.3mL · Injection · Intramuscular · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-584-02 | 7642005840276420058402 | 2 CONTAINER in 1 CARTON (76420-584-02) / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASSMarketed from Aug 29, 2023 |
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)
- Epipen
- Generic name (nonproprietary)
- epinephrine
- Active ingredients
- Epinephrine — .3 mg/.3mL
- Dosage form
- Injection
- Route
- Intramuscular
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019430
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Catecholamines (Chemical structure)
- Identifiers
- Product ID 76420-584_040d1b88-235a-aa09-e063-6394a90adbadSPL ID 040d1b88-235a-aa09-e063-6394a90adbadSPL set ID 311af6d9-20c0-4b87-b236-4185bfa49988RxCUI 727347, 1870207UNII 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.
EpiPen is an auto-injector dispensed to patients and is usually billed by NDC through a pharmacy benefit. J0171 applies to epinephrine administered in a clinical setting.
- 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
N476420058402followed by a unit qualifier and the quantityPackage 76420-0584-02. 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)
EpiPen are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. EpiPen are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and co…
Excerpt only. Read the full label for complete information.
About NDC 76420-584
- What is NDC 76420-584?
- 76420-584 is the product NDC for Epipen (epinephrine), Epinephrine .3 mg/.3mL injection, listed with the FDA by Asclemed USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Epipen (Epinephrine).
- What is the active ingredient?
- Epinephrine.
- Who is the labeler?
- Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Epipen?
- 1 other product NDC are listed under this name. See all Epipen NDCs.
- Is there a related HCPCS / J-code?
- Yes: J0171, Injection, adrenalin, epinephrine, 0.1 mg. See Billing references above.
Related NDCs: other Epipen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Epipenepinephrine | Epinephrine .3 mg/.3mL | InjectionIntramuscular | Viatris Specialty LLC | 49502-500 | 49502-0500-0249502-0500-92 |
Other NDCs under NDA 019430
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 .3 mg/.3mL | InjectionIntramuscular | Sportpharm LLC | 85766-304 |
| Epinephrine | Epinephrine .3 mg/.3mL | InjectionIntramuscular | Viatris Specialty LLC | 49502-102 |
| Epinephrine | Epinephrine .15 mg/.3mL | InjectionIntramuscular | Viatris Specialty LLC | 49502-101 |
| Epipen Jrepinephrine | Epinephrine .15 mg/.3mL | InjectionIntramuscular | Viatris Specialty LLC | 49502-501 |
| Epipenepinephrine | Epinephrine .3 mg/.3mL | InjectionIntramuscular | Viatris Specialty LLC | 49502-500 |
| Epinephrine | Epinephrine .3 mg/.3mL | InjectionIntramuscular | A-S Medication Solutions | 50090-4543 |
| Epinephrine | Epinephrine .3 mg/.3mL | InjectionIntramuscular | Medical Purchasing Solutions, LLC | 71872-7135 |
| Epinephrine | Epinephrine .15 mg/.3mL | InjectionIntramuscular | Medical Purchasing Solutions, LLC | 71872-7134 |
| Epinephrine | Epinephrine .15 mg/.3mL | InjectionIntramuscular | HF Acquisition Co LLC, DBA HealthFirst | 51662-1225 |
| Epinephrine | Epinephrine .3 mg/.3mL | InjectionIntramuscular | HF Acquisition Co LLC, DBA HealthFirst | 51662-1224 |
| Epinephrine 0.3 Adults | Epinephrine .3 mg/.3mL | InjectionIntramuscular | Sina Health Inc | 70385-2019 |
| Epinephrine 0.15 Pediatrics | Epinephrine .15 mg/.3mL | InjectionIntramuscular | Sina Health Inc | 70385-2020 |
| Epinephrine | Epinephrine .15 mg/.3mL | InjectionIntramuscular | Sportpharm LLC | 85766-303 |