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

**Launch Signal Score:** 75/100

| Field | Value |
|---|---|
| Product | epinephrine |
| Generic name | epinephrine |
| NDC | 68083-699 |
| Labeler | Gland Pharma Limited |
| Product type | HUMAN PRESCRIPTION DRUG |
| Approval pathway | ANDA |
| Application number | ANDA219239 |
| Dosage form | INJECTION |
| Route | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| Active ingredients | EPINEPHRINE 1 mg/mL |
| Marketing start | 2026-09-22 |
| Package configurations | 2 |

## 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=68083-699). 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comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn.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.