# Magnesium Sulfate (Magnesium Sulfate Heptahydrate) by SQUARE PHARMACEUTICALS PLC.: new human prescription drug listing

**Launch Signal Score:** 75/100

| Field | Value |
|---|---|
| Product | Magnesium Sulfate |
| Generic name | Magnesium Sulfate Heptahydrate |
| NDC | 76483-129 |
| Labeler | SQUARE PHARMACEUTICALS PLC. |
| Product type | HUMAN PRESCRIPTION DRUG |
| Approval pathway | ANDA |
| Application number | ANDA217461 |
| Dosage form | INJECTION, SOLUTION |
| Route | INTRAMUSCULAR, INTRAVENOUS |
| Active ingredients | MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL |
| Marketing start | 2026-10-30 |
| Package configurations | 4 |

## 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=76483-129). 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comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn.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.