Prescription drug · ANDA
Epinephrine NDC 67296-1946
Epinephrine .3 mg/.3mL · Injection · Intramuscular, Subcutaneous · Redpharm Drug
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-1946-2 | 6729619460267296194602 | 2 CONTAINER in 1 CARTON (67296-1946-2) / 1 SYRINGE in 1 CONTAINER / .3 mL in 1 SYRINGEMarketed from Nov 27, 2018 |
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
- Generic name (nonproprietary)
- epinephrine
- Active ingredients
- Epinephrine — .3 mg/.3mL
- Dosage form
- Injection
- Route
- Intramuscular, Subcutaneous
- Labeler
- Redpharm DrugNDC labeler code 67296
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090589
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Catecholamines (Chemical structure)
- Identifiers
- Product ID 67296-1946_3d92ba47-9b9a-b44f-e063-6394a90ac286SPL ID 3d92ba47-9b9a-b44f-e063-6394a90ac286SPL set ID 300ac735-4493-c02a-e063-6294a90a5bceRxCUI 1870207UNII YKH834O4BHUPC 0300935985275, 0300935986272
- 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
N467296194602followed by a unit qualifier and the quantityPackage 67296-1946-02. 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)
Epinephrine Injection, 0.3 mg and Epinephrine Injection, 0.15 mg 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. Epinephrine Injection, 0.3 mg and Epinephrine Injection, 0.15 mg are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individ…
Excerpt only. Read the full label for complete information.
About NDC 67296-1946
- What is NDC 67296-1946?
- 67296-1946 is the product NDC for Epinephrine, Epinephrine .3 mg/.3mL injection, listed with the FDA by Redpharm Drug. 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?
- Redpharm Drug, NDC labeler code 67296. 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 ANDA 090589
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/.3mL | InjectionIntramuscular, Subcutaneous | Teva Pharmaceuticals USA, Inc. | 0093-5985 |
| Epinephrine | Epinephrine .15 mg/.3mL | InjectionIntramuscular, Subcutaneous | A-S Medication Solutions | 50090-5254 |
| Epinephrine | Epinephrine .15 mg/.3mL | InjectionIntramuscular, Subcutaneous | Bryant Ranch Prepack | 63629-8801 |
| Epinephrine | Epinephrine .3 mg/.3mL | InjectionIntramuscular, Subcutaneous | REMEDYREPACK INC. | 70518-2283 |
| Epinephrine | Epinephrine .3 mg/.3mL | InjectionIntramuscular, Subcutaneous | Asclemed USA, Inc. | 76420-188 |
| Epinephrine | Epinephrine .3 mg/.3mL | InjectionIntramuscular, Subcutaneous | Sportpharm LLC | 85766-091 |