Prescription drug · ANDA
epinephrine NDC 0517-1171
Epinephrine 1 mg/mL · Injection, Solution · Intramuscular, Subcutaneous · American Regent, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0517-1171-10 | 00517117110 | 10 AMPULE in 1 BOX (0517-1171-10) / 1 mL in 1 AMPULE (0517-1171-01)Marketed from Jan 31, 2023 |
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
- Route
- Intramuscular, Subcutaneous
- Labeler
- American Regent, Inc.NDC labeler code 0517
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207568
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Catecholamines (Chemical structure)
- Identifiers
- Product ID 0517-1171_ca2af610-a1fe-420d-812c-d1ae3d07d6feSPL ID ca2af610-a1fe-420d-812c-d1ae3d07d6feSPL set ID 6add7604-71f6-4d8a-9447-17ad01fa839dRxCUI 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
N400517117110followed by a unit qualifier and the quantityPackage 00517-1171-10. 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 injection is a non-selective alpha and beta adrenergic agonist indicated for: Emergency treatment of allergic reactions (Type 1), including anaphylaxis ( 1.1 ) To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock ( 1.2 ) 1.1 Anaphylaxis Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. 1.2 Hypotension associated with Septic Shoc k Epinephrine injection is indicated to increase mean arterial blood pressure in adult patients …
Excerpt only. Read the full label for complete information.
About NDC 0517-1171
- What is NDC 0517-1171?
- 0517-1171 is the product NDC for epinephrine, Epinephrine 1 mg/mL injection, solution, listed with the FDA by American Regent, Inc.. It has 1 package NDC, 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?
- American Regent, Inc., NDC labeler code 0517. 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?
- 74 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 |