Prescription drug · NDA AUTHORIZED GENERIC
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloride NDC 52536-302
Polyethylene glycol 3350 420 g/4L + 3 more ingredients · Powder, For solution · Oral · Wilshire Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52536-302-01 | 5253603020152536030201 | 4 L in 1 BOTTLE (52536-302-01)Marketed from Apr 15, 2026 |
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)
- PEG 3350, sodium chloride, sodium bicarbonate and potassium chlorideSuffix: 3350, sodium chloride, sodium bicarbonate and potassium chloride
- Generic name (nonproprietary)
- polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride
- Active ingredients
- Polyethylene glycol 3350 — 420 g/4LSodium chloride — 11.2 g/4LSodium bicarbonate — 5.72 g/4LPotassium chloride — 1.48 g/4L
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Wilshire Pharmaceuticals, Inc.NDC labeler code 52536
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 019797
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)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 Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Potassium Compounds (Chemical structure)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 52536-302_4e442a72-b13b-4869-8a1d-59356095b091SPL ID 4e442a72-b13b-4869-8a1d-59356095b091SPL set ID 4e442a72-b13b-4869-8a1d-59356095b091RxCUI 801054UNII G2M7P15E5P, 451W47IQ8X, 8MDF5V39QO, 660YQ98I10UPC 0352536302012
- Pharmacologic class
- 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
N452536030201followed by a unit qualifier and the quantityPackage 52536-0302-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy in adults and pediatric patients aged 6 months or greater ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 52536-302
- What is NDC 52536-302?
- 52536-302 is the product NDC for PEG 3350, sodium chloride, sodium bicarbonate and potassium chloride, Polyethylene glycol 3350 420 g/4L + 3 more ingredients powder, for solution, listed with the FDA by Wilshire Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- PEG 3350, sodium chloride, sodium bicarbonate and potassium chloride (Polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride).
- What is the active ingredient?
- Polyethylene glycol 3350, Sodium chloride, Sodium bicarbonate, Potassium chloride.
- Who is the labeler?
- Wilshire Pharmaceuticals, Inc., NDC labeler code 52536. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for PEG 3350, sodium chloride, sodium bicarbonate and potassium chloride?
- 1 other product NDC are listed under this name. See all PEG 3350, sodium chloride, sodium bicarbonate and potassium chloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other PEG 3350, sodium chloride, sodium bicarbonate and potassium chloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| PEG-3350, sodium chloride, sodium bicarbonate and potassium chloridepolyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride | Polyethylene glycol 3350 420 g/4L + 3 more ingredients | Powder, For solutionOral | Affordable Pharmaceuticals, LLC | 10572-302 | 10572-0302-01 |
Other NDCs under NDA 019797
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 |
|---|---|---|---|---|
| PEG-3350, sodium chloride, sodium bicarbonate and potassium chloridepolyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride | Polyethylene glycol 3350 420 g/4L + 3 more ingredients | Powder, For solutionOral | Affordable Pharmaceuticals, LLC | 10572-302 |