Prescription drug · NDA AUTHORIZED GENERIC
epinephrine NDC 0115-1694
Epinephrine .3 mg/.3mL · Injection · Subcutaneous · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0115-1694-30 | 00115169430 | 1 CASE in 1 CARTON (0115-1694-30) / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASSMarketed from Apr 1, 2010 | |
| 0115-1694-49 | 00115169449 | 2 CASE in 1 CARTON (0115-1694-49) / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASSMarketed from Apr 1, 2010 |
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 — .3 mg/.3mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Amneal Pharmaceuticals of New York LLCNDC labeler code 0115
- 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 0115-1694_fdafd090-bed3-4f16-8ab1-fd1573aa633eSPL ID fdafd090-bed3-4f16-8ab1-fd1573aa633eSPL set ID e13f05f1-7d21-49bb-b8d5-24bf9301c3d7RxCUI 1870225, 1870230UNII YKH834O4BHUPC 0301151694491, 0301151695498
- 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
N400115169430followed by a unit qualifier and the quantityPackage 00115-1694-30. 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 for the emergency treatment of type I allergic reactions, including anaphylaxis in adult and pediatric patients who weigh 15 kg or greater. Epinephrine Injection is a alpha and beta-adrenergic receptor agonist, indicated for the emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 15 kg or greater. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0115-1694
- What is NDC 0115-1694?
- 0115-1694 is the product NDC for epinephrine, Epinephrine .3 mg/.3mL injection, listed with the FDA by Amneal Pharmaceuticals of New York 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?
- Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. 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 |
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 .15 mg/.15mL | InjectionSubcutaneous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1222 |
| Epinephrine | Epinephrine .3 mg/.3mL | InjectionSubcutaneous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1223 |
| 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 | REMEDYREPACK INC. | 70518-4573 |
| Epinephrine Pediatricsepinephrine 0.15 pediatrics | Epinephrine .15 mg/.15mL | InjectionSubcutaneous | Sina Health Inc | 70385-2038 |
| epinephrine | Epinephrine .15 mg/.15mL | InjectionSubcutaneous | Amneal Pharmaceuticals of New York LLC | 0115-1695 |
| Epinephrine 0.3 Adults | Epinephrine .3 mg/.3mL | InjectionSubcutaneous | Sina Health Inc | 70385-2022 |
| Epinephrine | Epinephrine .3 mg/.3mL | InjectionSubcutaneous | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0264 |
| epinephrine | Epinephrine .3 mg/.3mL | InjectionSubcutaneous | REMEDYREPACK INC. | 70518-2048 |
| epinephrine | Epinephrine .3 mg/.3mL | InjectionSubcutaneous | A-S Medication Solutions | 50090-3155 |
| epinephrine | Epinephrine .3 mg/.3mL | InjectionSubcutaneous | Sportpharm LLC | 85766-061 |
| epinephrine | Epinephrine .3 mg/.3mL | InjectionSubcutaneous | ASCLEMED USA INC. | 76420-467 |