Prescription drug · ANDA
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral NDC 64380-116
Sodium sulfate 17.5 g/177mL + 2 more ingredients · Solution · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-116-01 | 6438001160164380011601 | 2 BOTTLE in 1 CARTON (64380-116-01) / 177 mL in 1 BOTTLE (64380-116-02)Marketed from Jan 17, 2024 |
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)
- Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral
- Generic name (nonproprietary)
- sodium sulfate, potassium sulfate and magnesium sulfate oral
- Active ingredients
- Sodium sulfate — 17.5 g/177mLPotassium sulfate — 3.13 g/177mLMagnesium sulfate, Unspecified form — 1.6 g/177mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Strides Pharma Science LimitedNDC labeler code 64380
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215469
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (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)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 64380-116_d980e927-0950-4519-9399-4df67b42dfd2SPL ID d980e927-0950-4519-9399-4df67b42dfd2SPL set ID d48d8c59-68b9-4e28-86a4-eabf8b2003b0RxCUI 1120068UNII 0YPR65R21J, 1K573LC5TV, DE08037SAB
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N464380011601followed by a unit qualifier and the quantityPackage 64380-0116-01. 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)
Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older. Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adult and pediatric patients 12 years of age and older (1).
Excerpt only. Read the full label for complete information.
About NDC 64380-116
- What is NDC 64380-116?
- 64380-116 is the product NDC for Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral, Sodium sulfate 17.5 g/177mL + 2 more ingredients solution, listed with the FDA by Strides Pharma Science Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral.
- What is the active ingredient?
- Sodium sulfate, Potassium sulfate, Magnesium sulfate, Unspecified form.
- Who is the labeler?
- Strides Pharma Science Limited, NDC labeler code 64380. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral?
- 1 other product NDC are listed under this name. See all Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate oral | Sodium sulfate 17.5 g/177mL + 2 more ingredients | SolutionOral | Macleods Pharmaceuticals Limited | 33342-546 | 33342-0546-53 |