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NDC 63323-0064-02 Magnesium Sulfate 500 mg/mL Details
Magnesium Sulfate 500 mg/mL
Magnesium Sulfate is a INTRAMUSCULAR; INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is MAGNESIUM SULFATE HEPTAHYDRATE.
Product Information
| NDC | 63323-0064 |
|---|---|
| Product ID | 63323-064_331fa756-1a83-4b07-a373-486fbd0ca27a |
| Associated GPIs | 79400010402020 |
| GCN Sequence Number | 001417 |
| GCN Sequence Number Description | magnesium sulfate VIAL 500 MG/ML INJECTION |
| HIC3 | C1H |
| HIC3 Description | MAGNESIUM SALTS REPLACEMENT |
| GCN | 04163 |
| HICL Sequence Number | 000610 |
| HICL Sequence Number Description | MAGNESIUM SULFATE |
| Brand/Generic | Generic |
| Proprietary Name | Magnesium Sulfate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | MAGNESIUM SULFATE HEPTAHYDRATE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAMUSCULAR; INTRAVENOUS |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/mL |
| Substance Name | MAGNESIUM SULFATE HEPTAHYDRATE |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA019316 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0064-02 (63323006402)
| NDC Package Code | 63323-064-02 |
|---|---|
| Billing NDC | 63323006402 |
| Package | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-064-02) / 2 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2000-08-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |