Prescription drug · ANDA
epinephrine NDC 68083-699
Epinephrine 1 mg/mL · Injection · Intramuscular, Intravenous, Subcutaneous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-699-10 | 68083069910 | 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-699-10) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 22, 2026 | |
| 68083-699-25 | 68083069925 | 25 VIAL, SINGLE-DOSE in 1 CARTON (68083-699-25) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 22, 2026 |
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)
- epinephrine
- Generic name (nonproprietary)
- epinephrine
- Active ingredients
- Epinephrine — 1 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous, Subcutaneous
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219239
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Catecholamines (Chemical structure)
- Identifiers
- Product ID 68083-699_eec70351-16c3-4e07-9c0a-17ef8aa02161SPL ID eec70351-16c3-4e07-9c0a-17ef8aa02161
- 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
N468083069910followed by a unit qualifier and the quantityPackage 68083-0699-10. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 68083-699
- What is NDC 68083-699?
- 68083-699 is the product NDC for epinephrine, Epinephrine 1 mg/mL injection, listed with the FDA by Gland Pharma Limited. 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?
- Gland Pharma Limited, NDC labeler code 68083. 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 | HF Acquisition Co LLC, DBA HealthFirst | 51662-1708 | 51662-1708-03 |
| Epinephrine | Epinephrine 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0143-9476 | 00143-9476-25 |
| 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 |
| epinephrine | Epinephrine 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Gland Pharma Limited | 68083-685 | 68083-0685-01 |
Other NDCs under ANDA 219239
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 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Gland Pharma Limited | 68083-633 |
| epinephrine | Epinephrine 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Gland Pharma Limited | 68083-685 |
| epinephrine | Epinephrine 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | GLENMARK PHARMACEUTICALS INC., USA | 68462-760 |
| epinephrine | Epinephrine 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | GLENMARK PHARMACEUTICALS INC., USA | 68462-761 |