Prescription drug · ANDA
Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep kit NDC 51672-4170
sodium sulfate anhydrous, potassium sulfate, and magnesium sulfate · Sodium sulfate anhydrous 17.5 g/177mL + 2 more ingredients · Solution · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-4170-5 | 5167241700551672417005 | 2 BOTTLE in 1 CARTON (51672-4170-5) / 177 mL in 1 BOTTLEMarketed from Mar 27, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 Bowel Prep kit
- Generic name (nonproprietary)
- sodium sulfate anhydrous, potassium sulfate, and magnesium sulfate
- Active ingredients
- Sodium sulfate anhydrous — 17.5 g/177mLPotassium sulfate — 3.13 g/177mLMagnesium sulfate, Unspecified form — 1.6 g/177mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206431
- 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 51672-4170_494f52da-8ae6-6ec4-e063-6294a90a73a6SPL ID 494f52da-8ae6-6ec4-e063-6294a90a73a6SPL set ID 4adeeb11-0f3a-47d8-a664-376df50b05f2RxCUI 1001689, 1120068UNII 36KCS0R750, 1K573LC5TV, DE08037SABUPC 0351672417055
- 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
N451672417005followed by a unit qualifier and the quantityPackage 51672-4170-05. 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 SUPREPP® 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 51672-4170
- What is NDC 51672-4170?
- 51672-4170 is the product NDC for Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep kit, Sodium sulfate anhydrous 17.5 g/177mL + 2 more ingredients solution, listed with the FDA by Sun Pharmaceutical Industries, 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 Bowel Prep kit (Sodium sulfate anhydrous, potassium sulfate, and magnesium sulfate).
- What is the active ingredient?
- Sodium sulfate anhydrous, Potassium sulfate, Magnesium sulfate, Unspecified form.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. 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 Bowel Prep kit?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.