# OLMESARTAN MEDOXOMIL and HYDROCHOLOROTHIAZIDE (Olmesartan medoxomil and hydrocholorothiazide) by Micro Labs Limited: new human prescription drug listing

**Launch Signal Score:** 65/100

| Field | Value |
|---|---|
| Product | OLMESARTAN MEDOXOMIL and HYDROCHOLOROTHIAZIDE |
| Generic name | Olmesartan medoxomil and hydrocholorothiazide |
| NDC | 42571-204 |
| Labeler | Micro Labs Limited |
| Product type | HUMAN PRESCRIPTION DRUG |
| Approval pathway | ANDA |
| Application number | ANDA206371 |
| Dosage form | TABLET, FILM COATED |
| Route | ORAL |
| Active ingredients | OLMESARTAN MEDOXOMIL 20 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1 |
| Marketing start | 2026-10-15 |
| Package configurations | 4 |

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

Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=42571-204). 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comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn.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.