Prescription drug · ANDA
Levocarnitine NDC 36000-368
Levocarnitine 1 g/5mL · Injection, Solution · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36000-368-10 | 3600003681036000036810 | 10 VIAL, SINGLE-DOSE in 1 CARTON (36000-368-10) / 5 mL in 1 VIAL, SINGLE-DOSE (36000-368-01)Marketed from Jul 2, 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)
- Levocarnitine
- Generic name (nonproprietary)
- levocarnitine
- Active ingredients
- Levocarnitine — 1 g/5mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Baxter Healthcare CorporationNDC labeler code 36000
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217896
- Marketing start
- Listing expires
- Other FDA classes
- Carnitine (Chemical structure)
- Identifiers
- Product ID 36000-368_1f38ab0d-ef89-4e92-990f-9da190057e17SPL ID 1f38ab0d-ef89-4e92-990f-9da190057e17SPL set ID 1f38ab0d-ef89-4e92-990f-9da190057e17RxCUI 1791371UNII 0G389FZZ9M
- Pharmacologic class
- Carnitine Analog
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
N436000036810followed by a unit qualifier and the quantityPackage 36000-0368-10. 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)
INDICATIONS AND USAGE For the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency. For the prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis.
Excerpt only. Read the full label for complete information.
About NDC 36000-368
- What is NDC 36000-368?
- 36000-368 is the product NDC for Levocarnitine, Levocarnitine 1 g/5mL 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?
- Levocarnitine.
- What is the active ingredient?
- Levocarnitine.
- Who is the labeler?
- Baxter Healthcare Corporation, NDC labeler code 36000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Levocarnitine?
- 12 other product NDCs are listed under this name. See all Levocarnitine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Levocarnitine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| levocarnitine | Levocarnitine 1 g/5mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-681 | 68083-0681-05 |
| levocarnitine | Levocarnitine 1 g/5mL | Injection, SolutionIntravenous | Devatis Inc. | 73043-034 | 73043-0034-05 |
| Levocarnitinelevocarnitine oral | Levocarnitine 1 g/10mL | SolutionOral | Saptalis Pharmaceuticals, LLC | 71656-016 | 71656-0016-0171656-0016-0271656-0016-04+2 more |
| Levocarnitine | Levocarnitine 200 mg/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-1045 | 00517-1045-05 |
| Levocarnitine | Levocarnitine 200 mg/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-1075 | 00517-1075-01 |
| Levocarnitine | Levocarnitine 1 g/5mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9852 | 00143-9852-10 |
| Levocarnitine | Levocarnitine 330 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-492 | 70954-0492-10 |
| Levocarnitine | Levocarnitine 1 g/10mL | SolutionOral | TRUPHARMA, LLC | 52817-830 | 52817-0830-04 |
| Levocarnitine | Levocarnitine 330 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-762 | 16571-0762-09 |
| Levocarnitine | Levocarnitine 1 g/10mL | SolutionOral | ANI Pharmaceuticals, Inc. | 70954-139 | 70954-0139-10 |