Prescription drug · ANDA
Epinephrine NDC 50090-5254
Epinephrine .15 mg/.3mL · Injection · Intramuscular, Subcutaneous · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5254-0 | 50090525400 | 2 CONTAINER in 1 CARTON (50090-5254-0) / 1 mL in 1 CONTAINERMarketed from Oct 14, 2020 |
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 — .15 mg/.3mL
- Dosage form
- Injection
- Route
- Intramuscular, Subcutaneous
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090589
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Catecholamines (Chemical structure)
- Identifiers
- Product ID 50090-5254_42449017-67a2-4443-b5de-dbdce65bc95eSPL ID 42449017-67a2-4443-b5de-dbdce65bc95eSPL set ID ab5e23d0-6e99-4647-838d-23a4040602b5RxCUI 727316UNII 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
N450090525400followed by a unit qualifier and the quantityPackage 50090-5254-00. 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, 0.3 mg and Epinephrine Injection, 0.15 mg 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. Epinephrine Injection, 0.3 mg and Epinephrine Injection, 0.15 mg are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individ…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090589
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 .15 mg/.3mL | InjectionIntramuscular, Subcutaneous | Bryant Ranch Prepack | 63629-8801 |
| Epinephrine | Epinephrine .3 mg/.3mL | InjectionIntramuscular, Subcutaneous | Asclemed USA, Inc. | 76420-188 |
| Epinephrine | Epinephrine .3 mg/.3mL | InjectionIntramuscular, Subcutaneous | REMEDYREPACK INC. | 70518-2283 |
| Epinephrine | Epinephrine .3 mg/.3mL | InjectionIntramuscular, Subcutaneous | Redpharm Drug | 67296-1946 |
| Epinephrine | Epinephrine .3 mg/.3mL | InjectionIntramuscular, Subcutaneous | Sportpharm LLC | 85766-091 |
| Epinephrine | Epinephrine .15 mg/.3mL | InjectionIntramuscular, Subcutaneous | Teva Pharmaceuticals USA, Inc. | 0093-5985 |
| Epinephrine | Epinephrine .3 mg/.3mL | InjectionIntramuscular, Subcutaneous | Teva Pharmaceuticals USA, Inc. | 0093-5986 |