Prescription drug · NDA
Sutab NDC 52268-201
sodium sulfate, magnesium sulfate, and potassium chloride · Sodium sulfate 17.75 g/1 + 2 more ingredients · Tablet · Oral · Braintree Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52268-201-01 | 52268020101 | 2 BOTTLE, PLASTIC in 1 KIT (52268-201-01) / 12 TABLET in 1 BOTTLE, PLASTICMarketed from Nov 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)
- Sutab
- Generic name (nonproprietary)
- sodium sulfate, magnesium sulfate, and potassium chloride
- Active ingredients
- Sodium sulfate — 17.75 g/1Magnesium sulfate anhydrous — 2.7 g/1Potassium chloride — 2.25 g/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Braintree Laboratories, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213135
- 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)Potassium Compounds (Chemical structure)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 52268-201_093f5259-d407-4295-e063-6294a90abb17SPL ID 093f5259-d407-4295-e063-6294a90abb17SPL set ID dddd2701-4d46-44de-a9f8-303d4dcceef7UNII 0YPR65R21J, ML30MJ2U7I, 660YQ98I10
- Pharmacologic class
- Calculi Dissolution Agent; Osmotic Laxative; Potassium Salt
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
N452268020101followed by a unit qualifier and the quantityPackage 52268-0201-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under NDA 213135
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 |
|---|---|---|---|---|
| Sutabsodium sulfate, magnesium sulfate, and potassium chloride | Sodium sulfate 17.75 g/1 + 2 more ingredients | TabletOral | Azurity Pharmaceuticals, Inc. | 24338-201 |