# levocarnitine by Gland Pharma Limited: new human prescription drug listing

**Launch Signal Score:** 75/100

| Field | Value |
|---|---|
| Product | levocarnitine |
| Generic name | levocarnitine |
| NDC | 68083-681 |
| Labeler | Gland Pharma Limited |
| Product type | HUMAN PRESCRIPTION DRUG |
| Approval pathway | ANDA |
| Application number | ANDA220181 |
| Dosage form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active ingredients | LEVOCARNITINE 1 g/5mL |
| Marketing start | 2026-09-30 |
| Package configurations | 1 |

## Why this score
- Prescription or biologic product.
- New generic entry: wholesalers and GPOs re-bid contracts.
- Injectable: hospital and 503B relevance.

Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=68083-681). Last refreshed: 2026-11-04T18:12:05.743Z.
Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.