Prescription drug · ANDA
Magnesium Sulfate in Water (magnesium sulfate) NDC 44567-421
Magnesium sulfate heptahydrate 4 g/100mL · Injection · Intravenous · WG Critical Care, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44567-421-24 | 44567042124 | 24 POUCH in 1 CARTON (44567-421-24) / 1 BAG in 1 POUCH / 100 mL in 1 BAGMarketed from Jan 9, 2018 |
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 in Water
- Generic name (nonproprietary)
- magnesium sulfate
- Active ingredients
- Magnesium sulfate heptahydrate — 4 g/100mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- WG Critical Care, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207350
- 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 44567-421_afe639dd-97a2-4cde-8ae0-916566d39137SPL ID afe639dd-97a2-4cde-8ae0-916566d39137SPL set ID 752f55bb-c4ca-4545-94b3-3deea66888d4RxCUI 829734, 1658259, 1658262, 1658264, 1658265UNII SK47B8698TUPC 0344567424245, 0344567420247, 0344567421244
- 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
N444567042124followed by a unit qualifier and the quantityPackage 44567-0421-24. 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 in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207350
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 in Watermagnesium sulfate | Magnesium sulfate heptahydrate 40 g/1000mL | InjectionIntravenous | WG Critical Care, LLC | 44567-423 |
| Magnesium Sulfate in Watermagnesium sulfate | Magnesium sulfate heptahydrate 2 g/50mL | InjectionIntravenous | WG Critical Care, LLC | 44567-420 |
| Magnesium Sulfate in Watermagnesium sulfate | Magnesium sulfate heptahydrate 20 g/500mL | InjectionIntravenous | WG Critical Care, LLC | 44567-422 |
| Magnesium Sulfate in Watermagnesium sulfate | Magnesium sulfate heptahydrate 4 g/50mL | InjectionIntravenous | WG Critical Care, LLC | 44567-424 |