Prescription drug · NDA
Epinephrine NDC 54288-119
Epinephrine 1 mg/mL · Injection · Intramuscular, Intravenous, Subcutaneous · BPI Labs, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54288-119-10 | 5428801191054288011910 | 10 VIAL in 1 CARTON (54288-119-10) / 1 mL in 1 VIALMarketed from Mar 7, 2024 | |
| 54288-119-25 | 5428801192554288011925 | 25 VIAL in 1 CARTON (54288-119-25) / 1 mL in 1 VIALMarketed from Mar 7, 2024 |
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 — 1 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous, Subcutaneous
- Labeler
- BPI Labs, LLCNDC labeler code 54288
- 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 54288-119_cb28673a-ca0d-498d-94c4-cc2f34c3108bSPL ID cb28673a-ca0d-498d-94c4-cc2f34c3108bSPL set ID db18519b-82a9-435b-85c7-a040d644f057RxCUI 310132, 1660014UNII YKH834O4BHUPC 0354288119252, 0354288120012, 0354288119108, 0354288152013
- 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
N454288011910followed by a unit qualifier and the quantityPackage 54288-0119-10. 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) For emergency treatment of allergic reactions (Type 1), including anaphylaxis (1.2) 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 alle…
Excerpt only. Read the full label for complete information.
About NDC 54288-119
- What is NDC 54288-119?
- 54288-119 is the product NDC for Epinephrine, Epinephrine 1 mg/mL injection, listed with the FDA by BPI Labs, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Epinephrine.
- What is the active ingredient?
- Epinephrine.
- Who is the labeler?
- BPI Labs, LLC, NDC labeler code 54288. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Epinephrine?
- 75 other product NDCs are listed under this name. See all Epinephrine NDCs.
- Is there a related HCPCS / J-code?
- Yes: J0171, Injection, adrenalin, epinephrine, 0.1 mg. See Billing references above.
Related NDCs: other Epinephrine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| epinephrine | Epinephrine 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Gland Pharma Limited | 68083-699 | 68083-0699-1068083-0699-25 |
| Epinephrine | Epinephrine 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0143-9476 | 00143-9476-25 |
| Epinephrine | Epinephrine 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1708 | 51662-1708-03 |
| epinephrine | Epinephrine 1 mg/mL | Injection, Solution, ConcentrateIntramuscular, Intravenous, Subcutaneous | Baxter Healthcare Corporation | 43066-801 | 43066-0801-02 |
| epinephrine | Epinephrine 1 mg/mL | Injection, Solution, ConcentrateIntramuscular, Intravenous, Subcutaneous | Baxter Healthcare Corporation | 43066-803 | 43066-0803-25 |
| epinephrine | Epinephrine bitartrate 16 ug/mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0006 | 00338-0006-20 |
| epinephrine | Epinephrine .15 mg/.15mL | InjectionSubcutaneous | REMEDYREPACK INC. | 70518-4573 | 70518-4573-00 |
| epinephrine | Epinephrine 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | GLENMARK PHARMACEUTICALS INC., USA | 68462-761 | 68462-0761-30 |
| Epinephrine | Epinephrine 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Amneal Pharmaceuticals Private Limited | 80830-1659 | 80830-1659-02 |
| epinephrine | Epinephrine 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Amneal Pharmaceuticals LLC | 70121-1660 | 70121-1660-02 |
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, ConcentrateIntravenous | Henry Schein, Inc. | 0404-9857 |
| Epinephrine | Epinephrine 1 mg/mL | Injection, Solution, ConcentrateIntramuscular, Intraocular, Intravenous, Subcutaneous | A-S Medication Solutions | 50090-3039 |
| Epinephrine | Epinephrine 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1706 |
| Epinephrine | Epinephrine 1 mg/mL | Injection, Solution, ConcentrateIntramuscular, Intraocular, Intravenous, Subcutaneous | BPI Labs, LLC | 54288-103 |
| Epinephrine | Epinephrine 1 mg/mL | InjectionIntravenous | BPI Labs, LLC | 54288-117 |
| Epinephrine | Epinephrine 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | BPI Labs, LLC | 54288-120 |
| 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 | InjectionIntramuscular, Intravenous, Subcutaneous | REMEDYREPACK INC. | 70518-4156 |
| Epinephrine | Epinephrine 1 mg/mL | Injection, Solution, ConcentrateIntravenous | Medical Purchasing Solutions, LLC | 71872-7117 |
| 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 | ProPharma Distribution | 84549-103 |