Prescription drug · ANDA
levocarnitine NDC 68083-681
Levocarnitine 1 g/5mL · Injection, Solution · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-681-05 | 6808306810568083068105 | 5 VIAL, SINGLE-DOSE in 1 CARTON (68083-681-05) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 30, 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
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220181
- Marketing start
- Listing expires
- Other FDA classes
- Carnitine (Chemical structure)
- Identifiers
- Product ID 68083-681_e5af94a7-f7f4-40c8-aaef-f615df275e60SPL ID e5af94a7-f7f4-40c8-aaef-f615df275e60
- 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
N468083068105followed by a unit qualifier and the quantityPackage 68083-0681-05. 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 68083-681
- What is NDC 68083-681?
- 68083-681 is the product NDC for levocarnitine, Levocarnitine 1 g/5mL injection, solution, listed with the FDA by Gland Pharma Limited. 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?
- 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 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 | Baxter Healthcare Corporation | 36000-368 | 36000-0368-10 |
| 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 |