# LANGLARA (insulin glargine-aldy) by Lanexa Biologics, LLC: new human prescription drug listing

**Launch Signal Score:** 80/100

| Field | Value |
|---|---|
| Product | LANGLARA |
| Generic name | insulin glargine-aldy |
| NDC | 87682-090 |
| Labeler | Lanexa Biologics, LLC |
| Product type | HUMAN PRESCRIPTION DRUG |
| Approval pathway | BLA |
| Application number | BLA761412 |
| Dosage form | INJECTION, SOLUTION |
| Route | SUBCUTANEOUS |
| Active ingredients | INSULIN GLARGINE 100 [iU]/mL |
| Marketing start | 2026-07-01 |
| Package configurations | 1 |

## Why this score
- Prescription or biologic product.
- Brand or biologic launch.
- 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=87682-090). 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comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn.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.