# AMLODIPINE AND VALSARTAN (amlodipine and valsartan) by Cadila Pharmaceuticals Limited: new human prescription drug listing

**Launch Signal Score:** 65/100

| Field | Value |
|---|---|
| Product | AMLODIPINE AND VALSARTAN |
| Generic name | amlodipine and valsartan |
| NDC | 71209-023 |
| Labeler | Cadila Pharmaceuticals Limited |
| Product type | HUMAN PRESCRIPTION DRUG |
| Approval pathway | ANDA |
| Application number | ANDA205797 |
| Dosage form | TABLET, FILM COATED |
| Route | ORAL |
| Active ingredients | AMLODIPINE BESYLATE 5 mg/1; VALSARTAN 320 mg/1 |
| Marketing start | 2026-10-22 |
| Package configurations | 2 |

## 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=71209-023). 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comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn.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.