Prescription drug · ANDA
Levocarnitine (Levocarnitine oral) NDC 71656-016
Levocarnitine 1 g/10mL · Solution · Oral · Saptalis Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71656-016-01 | 7165600160171656001601 | 100 CUP, UNIT-DOSE in 1 TRAY (71656-016-01) / 5 mL in 1 CUP, UNIT-DOSE (71656-016-05)Marketed from Feb 21, 2024 | |
| 71656-016-02 | 7165600160271656001602 | 100 CUP, UNIT-DOSE in 1 TRAY (71656-016-02) / 10 mL in 1 CUP, UNIT-DOSE (71656-016-10)Marketed from Feb 21, 2024 | |
| 71656-016-04 | 7165600160471656001604 | 118 mL in 1 BOTTLE (71656-016-04)Marketed from Feb 21, 2024 | |
| 71656-016-50 | 7165600165071656001650 | 50 CUP, UNIT-DOSE in 1 TRAY (71656-016-50) / 5 mL in 1 CUP, UNIT-DOSE (71656-016-05)Marketed from Feb 21, 2024 | |
| 71656-016-51 | 7165600165171656001651 | 50 CUP, UNIT-DOSE in 1 TRAY (71656-016-51) / 10 mL in 1 CUP, UNIT-DOSE (71656-016-10)Marketed from Feb 21, 2024 |
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 oral
- Active ingredients
- Levocarnitine — 1 g/10mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Saptalis Pharmaceuticals, LLCNDC labeler code 71656
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212533
- Marketing start
- Listing expires
- Other FDA classes
- Carnitine (Chemical structure)
- Identifiers
- Product ID 71656-016_30a343cc-caab-d417-e063-6394a90ad77bSPL ID 30a343cc-caab-d417-e063-6394a90ad77bSPL set ID 75b43fb1-4486-48a0-b571-7754dce350a3RxCUI 315134UNII 0G389FZZ9MUPC 0371656016043
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471656001601followed by a unit qualifier and the quantityPackage 71656-0016-01. 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 Levocarnitine oral solution is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Associated symptoms included hypotonia, muscle weakness and failure to thrive. A diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see CLINICAL PHARMACOLOGY ). In some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly all…
Excerpt only. Read the full label for complete information.
About NDC 71656-016
- What is NDC 71656-016?
- 71656-016 is the product NDC for Levocarnitine (levocarnitine oral), Levocarnitine 1 g/10mL solution, listed with the FDA by Saptalis Pharmaceuticals, LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Levocarnitine (Levocarnitine Oral).
- What is the active ingredient?
- Levocarnitine.
- Who is the labeler?
- Saptalis Pharmaceuticals, LLC, NDC labeler code 71656. 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 | Baxter Healthcare Corporation | 36000-368 | 36000-0368-10 |
| levocarnitine | Levocarnitine 1 g/5mL | Injection, SolutionIntravenous | Devatis Inc. | 73043-034 | 73043-0034-05 |
| 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 |
Other NDCs under ANDA 212533
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 |
|---|---|---|---|---|
| Levocarnitine | Levocarnitine 1 g/10mL | SolutionOral | TRUPHARMA, LLC | 52817-830 |