Prescription drug · NDA
Magnesium Sulfate (magnesium sulfate heptahydrate) NDC 63323-642
Magnesium sulfate heptahydrate 500 mg/mL · Injection, Solution · Intramuscular, Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-642-20 | 63323064220 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-642-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-642-01)Marketed from Jan 29, 2016 | |
| 63323-642-50 | 63323064250 | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-642-50) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-642-02)Marketed from Jan 29, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Magnesium Sulfate
- Generic name (nonproprietary)
- magnesium sulfate heptahydrate
- Active ingredients
- Magnesium sulfate heptahydrate — 500 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019316
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Small Intestine Fluid/Electrolyte Absorption (Physiologic effect)Magnesium Ion Exchange Activity (Mechanism)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 63323-642_89d02988-a12e-4224-88f0-3f05f7ee324fSPL ID 89d02988-a12e-4224-88f0-3f05f7ee324fSPL set ID 77f70e00-3934-4fd9-a581-4cf3df8c42d2RxCUI 1658236, 1658245UNII SK47B8698TUPC 0363323642020, 0363323642013
- Pharmacologic class
- Calculi Dissolution Agent; Osmotic Laxative
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N463323064220followed by a unit qualifier and the quantityPackage 63323-0642-20. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE: Magnesium Sulfate Injection, USP is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. In such cases, the serum magnesium level is usually below the lower limit of normal (1.5 to 2.5 mEq/L) and the serum calcium level is normal (4.3 to 5.3 mEq/L) or elevated. In total parenteral nutrition (TPN), magnesium sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy. Magnesium sulfate injection is also indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, res…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 019316
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Magnesium Sulfate | Magnesium sulfate heptahydrate 500 mg/mL | Injection, SolutionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9904 |
| Magnesium Sulfate | Magnesium sulfate heptahydrate 500 mg/mL | Injection, SolutionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9902 |
| Magnesium Sulfatemagnesium sulfate heptahydrate | Magnesium sulfate heptahydrate 500 mg/mL | Injection, SolutionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7229 |
| Magnesium Sulfatemagnesium sulfate heptahydrate | Magnesium sulfate heptahydrate 500 mg/mL | Injection, SolutionIntramuscular, Intravenous | ProPharma Distribution | 84549-064 |
| Magnesium Sulfatemagnesium sulfate heptahydrate | Magnesium sulfate heptahydrate 500 mg/mL | Injection, SolutionIntramuscular, Intravenous | ProPharma Distribution | 84549-064 |
| Magnesium Sulfatemagnesium sulfate heptahydrate | Magnesium sulfate heptahydrate 500 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-064 |
| Magnesium Sulfatemagnesium sulfate heptahydrate | Magnesium sulfate heptahydrate 500 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-064 |
| Magnesium Sulfatemagnesium sulfate heptahydrate | Magnesium sulfate heptahydrate 500 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-064 |
| Magnesium Sulfatemagnesium sulfate heptahydrate | Magnesium sulfate heptahydrate 500 mg/mL | Injection, SolutionIntramuscular, Intravenous | REMEDYREPACK INC. | 70518-4375 |
| Magnesium Sulfate | Magnesium sulfate heptahydrate 500 mg/mL | Injection, SolutionIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1372 |
| Magnesium Sulfate | Magnesium sulfate heptahydrate 500 mg/mL | Injection, SolutionIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1390 |
| Magnesium Sulfatemagnesium sulfate heptahydrate | Magnesium sulfate heptahydrate 500 mg/mL | Injection, SolutionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7142 |