Prescription drug · NDA AUTHORIZED GENERIC
Epinephrine 0.3 Adults NDC 70385-2022
Epinephrine .3 mg/.3mL · Injection · Subcutaneous · Sina Health Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70385-2022-1 | 70385202201 | 1 CASE in 1 PACKAGE (70385-2022-1) / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASSMarketed from Apr 1, 2010 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 0.3 Adults
- Generic name (nonproprietary)
- epinephrine 0.3 adults
- Active ingredients
- Epinephrine — .3 mg/.3mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Sina Health IncNDC labeler code 70385
- 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 70385-2022_48356139-7818-c76a-e063-6394a90a5e80SPL ID 48356139-7818-c76a-e063-6394a90a5e80SPL set ID 28642ad9-b839-ce3a-e063-6394a90ab866RxCUI 1870230UNII 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
N470385202201followed by a unit qualifier and the quantityPackage 70385-2022-01. 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)
Epinephrine injection is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which includes 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. Epinephrine injection is 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 withi…
Excerpt only. Read the full label for complete information.
About NDC 70385-2022
- What is NDC 70385-2022?
- 70385-2022 is the product NDC for Epinephrine 0.3 Adults, Epinephrine .3 mg/.3mL injection, listed with the FDA by Sina Health Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Epinephrine 0.3 Adults.
- What is the active ingredient?
- Epinephrine.
- Who is the labeler?
- Sina Health Inc, NDC labeler code 70385. 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 0.3 Adults?
- 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 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 .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 .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. | 76420-467 |
| 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 .3 mg/.3mL | InjectionSubcutaneous | Amneal Pharmaceuticals of New York LLC | 0115-1694 |
| epinephrine | Epinephrine .15 mg/.15mL | InjectionSubcutaneous | Amneal Pharmaceuticals of New York LLC | 0115-1695 |