Prescription drug · NDA AUTHORIZED GENERIC
epinephrine NDC 85766-061
Epinephrine .3 mg/.3mL · Injection · Subcutaneous · Sportpharm LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85766-061-01 | 85766006101 | 1 CASE in 1 CARTON (85766-061-01) / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASSMarketed from Feb 3, 2026 | |
| 85766-061-02 | 85766006102 | 2 CASE in 1 CARTON (85766-061-02) / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASSMarketed from Sep 4, 2025 |
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)
- epinephrine
- Generic name (nonproprietary)
- epinephrine
- Active ingredients
- Epinephrine — .3 mg/.3mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Sportpharm LLC
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020800
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Catecholamines (Chemical structure)
- Identifiers
- Product ID 85766-061_49ee1012-eece-2e47-e063-6294a90add16SPL ID 49ee1012-eece-2e47-e063-6294a90add16SPL set ID e7798493-9407-4a5d-9c90-0cc336c59ec1RxCUI 1870230UNII 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
N485766006101followed by a unit qualifier and the quantityPackage 85766-0061-01. 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 injection is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which includes 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. Epinephrine injection is 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 withi…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020800
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 | InjectionSubcutaneous | A-S Medication Solutions | 50090-3155 |
| epinephrine | Epinephrine .3 mg/.3mL | InjectionSubcutaneous | REMEDYREPACK INC. | 70518-2048 |
| Epinephrine | Epinephrine .3 mg/.3mL | InjectionSubcutaneous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1223 |
| Epinephrine | Epinephrine .15 mg/.15mL | InjectionSubcutaneous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1222 |
| Epinephrine | Epinephrine .3 mg/.3mL | InjectionSubcutaneous | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0264 |
| Epinephrine Pediatricsepinephrine 0.15 pediatrics | Epinephrine .15 mg/.15mL | InjectionSubcutaneous | Sina Health Inc | 70385-2038 |
| epinephrine | Epinephrine .15 mg/.15mL | InjectionSubcutaneous | REMEDYREPACK INC. | 70518-4573 |
| Epinephrine 0.3 Adults | Epinephrine .3 mg/.3mL | InjectionSubcutaneous | Sina Health Inc | 70385-2022 |
| epinephrine | Epinephrine .3 mg/.3mL | InjectionSubcutaneous | ASCLEMED USA INC. | 76420-467 |
| epinephrine | Epinephrine .3 mg/.3mL | InjectionSubcutaneous | Amneal Pharmaceuticals of New York LLC | 0115-1694 |
| epinephrine | Epinephrine .3 mg/.3mL | InjectionSubcutaneous | Asclemed USA, Inc. | 76420-834 |
| epinephrine | Epinephrine .15 mg/.15mL | InjectionSubcutaneous | Asclemed USA, Inc. | 76420-835 |
| epinephrine | Epinephrine .15 mg/.15mL | InjectionSubcutaneous | Amneal Pharmaceuticals of New York LLC | 0115-1695 |
- Source
- FDA NDC Directory via openFDA; FDA SPL via openFDA and DailyMed; Med-Code HCPCS directory (curated)
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.