Prescription drug · ANDA
Magnesium Sulfate (Magnesium sulfate heptahydrate) NDC 68083-396
Magnesium sulfate heptahydrate 2 g/50mL · Injection, Solution · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-396-01 | 6808303960168083039601 | 24 POUCH in 1 CASE (68083-396-01) / 1 BAG in 1 POUCH / 50 mL in 1 BAGMarketed from Jul 10, 2020 |
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 — 2 g/50mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213917
- 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 68083-396_4166c4fd-2951-4ab0-ab2a-6da9dd39927eSPL ID 4166c4fd-2951-4ab0-ab2a-6da9dd39927eSPL set ID a9e706ac-9c5f-4b14-b277-53dee195ffc6RxCUI 1658259, 1658262UNII SK47B8698TUPC 0368083397012, 0368083396015
- 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
N468083039601followed by a unit qualifier and the quantityPackage 68083-0396-01. 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 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.
About NDC 68083-396
- What is NDC 68083-396?
- 68083-396 is the product NDC for Magnesium Sulfate (magnesium sulfate heptahydrate), Magnesium sulfate heptahydrate 2 g/50mL injection, solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, 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?
- Gland Pharma Limited, NDC labeler code 68083. 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 |
Other NDCs under ANDA 213917
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 Sulfatemagnesium sulfate heptahydrate | Magnesium sulfate heptahydrate 40 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-612 |
| Magnesium Sulfatemagnesium sulfate heptahydrate | Magnesium sulfate heptahydrate 40 mg/mL | Injection, SolutionIntravenous | Sun Pharmaceutical Industries, Inc. | 47335-992 |
| Magnesium Sulfatemagnesium sulfate heptahydrate | Magnesium sulfate heptahydrate 4 g/100mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-397 |