Prescription drug · ANDA
Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate NDC 43386-700
Sodium sulfate 17.5 g/177mL + 2 more ingredients · Solution · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43386-700-83 | 4338607008343386070083 | 2 BOTTLE in 1 CARTON (43386-700-83) / 177 mL in 1 BOTTLEMarketed from Dec 30, 2022 |
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, Magnesium Sulfate
- Generic name (nonproprietary)
- sodium sulfate, potassium sulfate, 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
- Lupin Pharmaceuticals, Inc.NDC labeler code 43386
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202511
- 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 43386-700_9fffaef0-0578-452d-a365-166b183d8e00SPL ID 9fffaef0-0578-452d-a365-166b183d8e00SPL set ID d4883657-d27d-4056-a567-5fb12d5e05d1RxCUI 1001689, 1120068UNII 0YPR65R21J, 1K573LC5TV, ML30MJ2U7I
- 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
N443386070083followed by a unit qualifier and the quantityPackage 43386-0700-83. 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 adults. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 43386-700
- What is NDC 43386-700?
- 43386-700 is the product NDC for Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate, Sodium sulfate 17.5 g/177mL + 2 more ingredients solution, listed with the FDA by Lupin Pharmaceuticals, 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, Magnesium Sulfate.
- What is the active ingredient?
- Sodium sulfate, Potassium sulfate, Magnesium sulfate anhydrous.
- Who is the labeler?
- Lupin Pharmaceuticals, Inc., NDC labeler code 43386. 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, Magnesium Sulfate?
- 1 other product NDC are listed under this name. See all Sodium Sulfate, Potassium Sulfate, 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, 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, Magnesium Sulfate | Sodium sulfate 17.5 g/177mL + 2 more ingredients | SolutionOral | Novel Laboratories, Inc. | 40032-700 | 40032-0700-83 |
Other NDCs under ANDA 202511
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, Magnesium Sulfate | Sodium sulfate 17.5 g/177mL + 2 more ingredients | SolutionOral | Novel Laboratories, Inc. | 40032-700 |