Prescription drug · ANDA
sodium sulfate, potassium sulfate, and magnesium sulfate NDC 69452-428
Sodium sulfate 17.5 g/177mL + 2 more ingredients · Solution · Oral · Bionpharma Inc.,
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-428-62 | 6945204286269452042862 | 2 BOTTLE, PLASTIC in 1 KIT (69452-428-62) / 177 mL in 1 BOTTLE, PLASTICMarketed from Apr 15, 2025 |
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 anhydrous — 1.6 g/177mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Bionpharma Inc.,NDC labeler code 69452
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204135
- 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 69452-428_557ef7f3-3db5-98bc-e063-6394a90af8acSPL ID 557ef7f3-3db5-98bc-e063-6394a90af8acSPL set ID 31d13799-0931-7735-e063-6294a90a6d02RxCUI 1001689, 1120068UNII 0YPR65R21J, 1K573LC5TV, ML30MJ2U7IUPC 0369452428979
- 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
N469452042862followed by a unit qualifier and the quantityPackage 69452-0428-62. 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 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.
About NDC 69452-428
- What is NDC 69452-428?
- 69452-428 is the product NDC for sodium sulfate, potassium sulfate, and magnesium sulfate, Sodium sulfate 17.5 g/177mL + 2 more ingredients solution, listed with the FDA by Bionpharma Inc.,. 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.
- What is the active ingredient?
- Sodium sulfate, Potassium sulfate, Magnesium sulfate anhydrous.
- Who is the labeler?
- Bionpharma Inc.,, NDC labeler code 69452. 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?
- 7 other product NDCs are listed under this name. See all sodium sulfate, potassium sulfate, and 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 sodium sulfate, potassium sulfate, and 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) |
|---|---|---|---|---|---|
| Sodium Sulfate, Potassium Sulfate And Magnesium Sulfatesodium sulfate, potassium sulfate, magnesium sulfate | Sodium sulfate 17.5 g/mL + 2 more ingredients | Solution, ConcentrateOral | Wilshire Pharmaceuticals, Inc. | 52536-175 | 52536-0175-01 |
| Sodium Sulfate, Potassium Sulfate And Magnesium Sulfatesodium sulfate, potassium sulfate, magnesium sulfate | Sodium sulfate 13.13 g/133.1mL + 2 more ingredients | Solution, ConcentrateOral | Wilshire Pharmaceuticals, Inc. | 52536-177 | 52536-0177-01 |
| Sodium sulfate, potassium sulfate and magnesium sulfate | Sodium sulfate 17.5 g/177mL + 2 more ingredients | SolutionOral | NorthStar RxLLC | 72603-278 | 72603-0278-02 |
| Sodium sulfate, potassium sulfate and magnesium sulfate | Sodium sulfate 17.5 g/177mL + 2 more ingredients | SolutionOral | Camber Pharmaceuticals, Inc. | 31722-098 | 31722-0098-31 |
| Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate | Sodium sulfate 17.5 g/177mL + 2 more ingredients | SolutionOral | Ascend Laboratories, LLC | 67877-725 | 67877-0725-92 |
| Sodium Sulfate, Potassium Sulfate And Magnesium Sulfatesodium sulfate, potassium sulfate, magnesium sulfate | Sodium sulfate 17.5 g/mL + 2 more ingredients | Solution, ConcentrateOral | Affordable Pharmaceuticals, LLC | 10572-012 | 10572-0012-01 |
| Sodium Sulfate, Potassium Sulfate And Magnesium Sulfatesodium sulfate, potassium sulfate, magnesium sulfate | Sodium sulfate 13.13 g/133.1mL + 2 more ingredients | Solution, ConcentrateOral | Affordable Pharmaceuticals, LLC | 10572-112 | 10572-0112-01 |