# Sodium Bicarbonate by Amneal Pharmaceuticals Private Limited: new human prescription drug listing

**Launch Signal Score:** 80/100

| Field | Value |
|---|---|
| Product | Sodium Bicarbonate |
| Generic name | Sodium Bicarbonate |
| NDC | 80830-2613 |
| Labeler | Amneal Pharmaceuticals Private Limited |
| Product type | HUMAN PRESCRIPTION DRUG |
| Approval pathway | NDA |
| Application number | NDA220790 |
| Dosage form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active ingredients | SODIUM BICARBONATE 12.6 mg/mL |
| Marketing start | 2026-07-13 |
| 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=80830-2613). Last refreshed: 2026-11-03T18:09:00.764Z.
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comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn.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.