Prescription drug · NDA
Epipen Jr (Epinephrine) NDC 49502-501
Epinephrine .15 mg/.3mL · Injection · Intramuscular · Viatris Specialty LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49502-501-02 | 49502050102 | 2 CONTAINER in 1 CARTON (49502-501-02) / 1 SYRINGE, GLASS in 1 CONTAINER (49502-501-01) / .3 mL in 1 SYRINGE, GLASSMarketed from Dec 22, 1987 | |
| 49502-501-92 | 49502050192 | 2 CONTAINER in 1 CARTON (49502-501-92) / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASSMarketed from Dec 22, 1987 · Sample package |
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)
- Epipen Jr
- Generic name (nonproprietary)
- epinephrine
- Active ingredients
- Epinephrine — .15 mg/.3mL
- Dosage form
- Injection
- Route
- Intramuscular
- Labeler
- Viatris Specialty LLCNDC labeler code 49502
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019430
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Catecholamines (Chemical structure)
- Identifiers
- Product ID 49502-501_81569d26-e9b3-4c1d-ac34-8a4cf5b4a98bSPL ID 81569d26-e9b3-4c1d-ac34-8a4cf5b4a98bSPL set ID 7560c201-9246-487c-a13b-6295db04274aRxCUI 727316, 727347, 727386, 1870207UNII 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.
EpiPen is an auto-injector dispensed to patients and is usually billed by NDC through a pharmacy benefit. J0171 applies to epinephrine administered in a clinical setting.
- 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
N449502050102followed by a unit qualifier and the quantityPackage 49502-0501-02. 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)
EpiPen and EpiPen Jr 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. EpiPen and EpiPen Jr are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within m…
Excerpt only. Read the full label for complete information.
About NDC 49502-501
- What is NDC 49502-501?
- 49502-501 is the product NDC for Epipen Jr (epinephrine), Epinephrine .15 mg/.3mL injection, listed with the FDA by Viatris Specialty LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Epipen Jr (Epinephrine).
- What is the active ingredient?
- Epinephrine.
- Who is the labeler?
- Viatris Specialty LLC, NDC labeler code 49502. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Epipen Jr?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Yes: J0171, Injection, adrenalin, epinephrine, 0.1 mg. See Billing references above.
Other NDCs under NDA 019430
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 |
|---|---|---|---|---|
| Epipenepinephrine | Epinephrine .3 mg/.3mL | InjectionIntramuscular | Asclemed USA, Inc. | 76420-584 |
| Epinephrine | Epinephrine .15 mg/.3mL | InjectionIntramuscular | Medical Purchasing Solutions, LLC | 71872-7134 |
| Epinephrine | Epinephrine .3 mg/.3mL | InjectionIntramuscular | Medical Purchasing Solutions, LLC | 71872-7135 |
| Epinephrine | Epinephrine .15 mg/.3mL | InjectionIntramuscular | Viatris Specialty LLC | 49502-101 |
| Epinephrine | Epinephrine .3 mg/.3mL | InjectionIntramuscular | Viatris Specialty LLC | 49502-102 |
| Epipenepinephrine | Epinephrine .3 mg/.3mL | InjectionIntramuscular | Viatris Specialty LLC | 49502-500 |
| Epinephrine | Epinephrine .3 mg/.3mL | InjectionIntramuscular | A-S Medication Solutions | 50090-4543 |
| Epinephrine | Epinephrine .3 mg/.3mL | InjectionIntramuscular | HF Acquisition Co LLC, DBA HealthFirst | 51662-1224 |
| Epinephrine | Epinephrine .15 mg/.3mL | InjectionIntramuscular | HF Acquisition Co LLC, DBA HealthFirst | 51662-1225 |
| Epinephrine 0.15 Pediatrics | Epinephrine .15 mg/.3mL | InjectionIntramuscular | Sina Health Inc | 70385-2020 |
| Epinephrine 0.3 Adults | Epinephrine .3 mg/.3mL | InjectionIntramuscular | Sina Health Inc | 70385-2019 |