Prescription drug · NDA
epinephrine NDC 0338-0006
Epinephrine bitartrate 16 ug/mL · Injection, Solution · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-0006-20 | 00338000620 | 20 BAG in 1 CARTON (0338-0006-20) / 250 mL in 1 BAGMarketed from Mar 16, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 bitartrate — 16 ug/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Baxter Healthcare CorporationNDC labeler code 0338
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 218475
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Catecholamines (Chemical structure)
- Identifiers
- Product ID 0338-0006_3c9127c0-60ca-4488-b8f6-d423343a0241SPL ID 3c9127c0-60ca-4488-b8f6-d423343a0241SPL set ID 60efd409-3555-4182-a68d-1cd7bc0d1bfcRxCUI 2695029, 2707568UNII 30Q7KI53AK
- 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 codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- 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
N400338000620followed by a unit qualifier and the quantityPackage 00338-0006-20. 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 in 0.9% Sodium Chloride Injection 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 ) 1.1 Hypotension associated with Septic Shock Epinephrine in 0.9% Sodium Chloride Injection is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
Excerpt only. Read the full label for complete information.
About NDC 0338-0006
- What is NDC 0338-0006?
- 0338-0006 is the product NDC for epinephrine, Epinephrine bitartrate 16 ug/mL injection, solution, listed with the FDA by Baxter Healthcare Corporation. 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 bitartrate.
- Who is the labeler?
- Baxter Healthcare Corporation, NDC labeler code 0338. 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?
- Not in Med-Code's curated HCPCS directory. 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 .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 NDA 218475
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 bitartrate 64 ug/mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0024 |