Prescription drug · ANDA
Sodium sulfate, potassium sulfate and magnesium sulfate NDC 31722-098
Sodium sulfate 17.5 g/177mL + 2 more ingredients · Solution · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-098-31 | 31722009831 | 2 BOTTLE, PLASTIC in 1 CARTON (31722-098-31) / 177 mL in 1 BOTTLE, PLASTIC (31722-098-17)Marketed from Oct 18, 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
- Generic name (nonproprietary)
- sodium sulfate, potassium sulfate and magnesium sulfate
- Active ingredients
- Sodium sulfate — 17.5 g/177mLPotassium sulfate — 3.13 g/177mLMagnesium sulfate — 1.6 g/177mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212903
- 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 31722-098_2be51483-8976-9653-e063-6394a90ad0bcSPL ID 2be51483-8976-9653-e063-6394a90ad0bcSPL set ID 315c377b-a634-45ea-9beb-c0f58dad551dRxCUI 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
N431722009831followed by a unit qualifier and the quantityPackage 31722-0098-31. 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 . This label includes a boxed warning.
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 patients. Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREP BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 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 patients. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212903
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 |
|---|---|---|---|---|
| Sodium sulfate, potassium sulfate and magnesium sulfate | Sodium sulfate 17.5 g/177mL + 2 more ingredients | SolutionOral | NorthStar RxLLC | 72603-278 |