Prescription drug · NDA
Epinephrine NDC 0404-9857
Epinephrine 1 mg/mL · Injection, Solution, Concentrate · Intravenous · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9857-01 | 00404985701 | 1 AMPULE in 1 BAG (0404-9857-01) / 1 mL in 1 AMPULEMarketed from Jan 10, 2022 |
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)
- Epinephrine
- Generic name (nonproprietary)
- epinephrine
- Active ingredients
- Epinephrine — 1 mg/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Henry Schein, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205029
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Catecholamines (Chemical structure)
- Identifiers
- Product ID 0404-9857_f9cff631-655e-45b8-b870-e7504142977dSPL ID f9cff631-655e-45b8-b870-e7504142977dSPL set ID af10f2bb-b0ad-45a6-b525-e715613350afRxCUI 1660014UNII 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
N400404985701followed by a unit qualifier and the quantityPackage 00404-9857-01. 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)
1.1 Hypotension associated with Septic Shock Epinephrine Injection USP, 1 mg/mL is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. 1.2 Anaphylaxis Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from allergic reactions to insect stings, biting insects, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. The signs and symptoms associated with anaphylaxis include flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with hypotension, convulsions, vomiting, diarrhea a…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 205029
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 | Injection, Solution, ConcentrateIntramuscular, Intraocular, Intravenous, Subcutaneous | A-S Medication Solutions | 50090-3039 |
| Epinephrine | Epinephrine 1 mg/mL | Injection, Solution, ConcentrateIntramuscular, Intraocular, Intravenous, Subcutaneous | ProPharma Distribution | 84549-103 |
| Epinephrine | Epinephrine 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Medical Purchasing Solutions, LLC. | 71872-7360 |
| Epinephrine | Epinephrine 1 mg/mL | Injection, Solution, ConcentrateIntramuscular, Intraocular, Intravenous, Subcutaneous | BPI Labs, LLC | 54288-103 |
| Epinephrine | Epinephrine 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | BPI Labs, LLC | 54288-120 |
| Epinephrine | Epinephrine 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1706 |
| Epinephrine | Epinephrine 1 mg/mL | InjectionIntravenous | BPI Labs, LLC | 54288-117 |
| Epinephrine | Epinephrine 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | BPI Labs, LLC | 54288-119 |
| Epinephrine | Epinephrine 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | REMEDYREPACK INC. | 70518-4156 |
| Epinephrine | Epinephrine 30 mg/30mL | InjectionIntramuscular, Intravenous, Subcutaneous | BPI Labs, LLC | 54288-152 |
| Epinephrine | Epinephrine 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | BPI Labs, LLC | 54288-600 |
| Epinephrine | Epinephrine 1 mg/mL | Injection, Solution, ConcentrateIntravenous | Medical Purchasing Solutions, LLC | 71872-7117 |