Prescription drug · ANDA
Magnesium Sulfate (Magnesium sulfate heptahydrate) NDC 76483-129
Magnesium sulfate heptahydrate 500 mg/mL · Injection, Solution · Intramuscular, Intravenous · SQUARE PHARMACEUTICALS PLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76483-129-01 | 7648301290176483012901 | 25 VIAL in 1 CARTON (76483-129-01) / 2 mL in 1 VIAL (76483-129-00)Marketed from Oct 30, 2026 | |
| 76483-129-03 | 7648301290376483012903 | 25 VIAL in 1 CARTON (76483-129-03) / 10 mL in 1 VIAL (76483-129-02)Marketed from Oct 30, 2026 | |
| 76483-129-05 | 7648301290576483012905 | 25 VIAL in 1 CARTON (76483-129-05) / 20 mL in 1 VIAL (76483-129-04)Marketed from Oct 30, 2026 | |
| 76483-129-07 | 7648301290776483012907 | 25 VIAL in 1 CARTON (76483-129-07) / 50 mL in 1 VIAL (76483-129-06)Marketed from Oct 30, 2026 |
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
- SQUARE PHARMACEUTICALS PLC.NDC labeler code 76483
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217461
- 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 76483-129_878a167e-0654-43a3-9d0b-3e5b4724e257SPL ID 878a167e-0654-43a3-9d0b-3e5b4724e257SPL set ID 5a18118e-6370-4473-adb2-084d66667ebcRxCUI 1658221, 1658236, 1658244, 1658245UNII SK47B8698TUPC 0376483129065, 0376483129041, 0376483129003, 0376483129027
- 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
N476483012901followed by a unit qualifier and the quantityPackage 76483-0129-01. 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.
About NDC 76483-129
- What is NDC 76483-129?
- 76483-129 is the product NDC for Magnesium Sulfate (magnesium sulfate heptahydrate), Magnesium sulfate heptahydrate 500 mg/mL injection, solution, listed with the FDA by SQUARE PHARMACEUTICALS PLC.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Magnesium Sulfate (Magnesium Sulfate Heptahydrate).
- What is the active ingredient?
- Magnesium sulfate heptahydrate.
- Who is the labeler?
- SQUARE PHARMACEUTICALS PLC., NDC labeler code 76483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Magnesium Sulfate?
- 29 other product NDCs are listed under this name. See all Magnesium Sulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Magnesium Sulfate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Magnesium Sulfatemagnesium sulfate heptahydrate | Magnesium sulfate heptahydrate 3 g/100mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-6353 | 00338-6353-40 |
| Magnesium Sulfatemagnesium sulfate heptahydrate | Magnesium sulfate heptahydrate 500 mg/mL | Injection, SolutionIntramuscular, Intravenous | REMEDYREPACK INC. | 70518-4375 | 70518-4375-0070518-4375-02 |
| Magnesium Sulfatemagnesium sulfate heptahydrate | Magnesium sulfate heptahydrate 500 mg/mL | Injection, SolutionIntramuscular, Intravenous | Camber Pharmaceuticals, Inc. | 31722-394 | 31722-0394-3231722-0394-3331722-0394-34+1 more |
| Magnesium Sulfatemagnesium sulfate heptahydrate | Magnesium sulfate heptahydrate 500 mg/mL | Injection, SolutionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7381 | 71872-7381-01 |
| Magnesium Sulfatemagnesium sulfate in water for | Magnesium sulfate heptahydrate 40 mg/mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1719 | 70121-1719-0270121-1719-09 |
| Magnesium Sulfatemagnesium sulfate in water for | Magnesium sulfate heptahydrate 40 mg/mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1720 | 70121-1720-0370121-1720-09 |
| Magnesium Sulfate | Magnesium sulfate heptahydrate 500 mg/mL | Injection, SolutionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9904 | 00404-9904-02 |
| Magnesium Sulfate | Magnesium sulfate heptahydrate 500 mg/mL | Injection, SolutionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9902 | 00404-9902-20 |
| Magnesium Sulfatemagnesium sulfate heptahydrate | Magnesium sulfate heptahydrate 500 mg/mL | Injection, SolutionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9903 | 00404-9903-10 |
| Magnesium Sulfatemagnesium sulfate heptahydrate | Magnesium sulfate heptahydrate 40 mg/mL | Injection, SolutionIntravenous | Sun Pharmaceutical Industries, Inc. | 47335-992 | 47335-0992-0147335-0992-02 |