Prescription drug · ANDA
epinephrine NDC 68462-933
Epinephrine 1 mg/mL · Injection, Solution, Concentrate · Intramuscular, Intraocular, Intravenous, Subcutaneous · GLENMARK PHARMACEUTICALS INC., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-933-10 | 68462093310 | 10 AMPULE in 1 BOX (68462-933-10) / 1 mL in 1 AMPULE (68462-933-01)Marketed from Jun 3, 2025 |
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, Solution, Concentrate
- Route
- Intramuscular, Intraocular, Intravenous, Subcutaneous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218144
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Catecholamines (Chemical structure)
- Identifiers
- Product ID 68462-933_e77f1aa3-df4b-4129-b72f-e9a4122a8f55SPL ID e77f1aa3-df4b-4129-b72f-e9a4122a8f55SPL set ID 01fd19cd-190c-4989-b733-60ba95941297RxCUI 1660014UNII YKH834O4BHUPC 0368462933107
- 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
N468462093310followed by a unit qualifier and the quantityPackage 68462-0933-10. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Epinephrine is a non-selective alpha and beta adrenergic agonist indicated: • To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. ( 1.1 ) • For emergency treatment of allergic reactions (Type 1), including anaphylaxis. ( 1.2 ) • For induction and maintenance of mydriasis during intraocular surgery. ( 1.3 ) 1.1 Hypotension associated with Septic Shock Epinephrine Injection, 1 mg/mL is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. 1.2 Anaphylaxis Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from allergic reactions to insect s…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218144
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 | Injection, Solution, ConcentrateIntramuscular, Intraocular, Intravenous, Subcutaneous | Gland Pharma Limited | 68083-591 |