NDC codes

FDA NDC Directory
Product NDC (as listed)10572-302Labeler and product segments. Claims need a package NDC.
Product NDC at billing width10572-0302Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
10572-302-0110572030201105720302014 L in 1 BOTTLE (10572-302-01)Marketed from Mar 1, 2013

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

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
Affordable Pharmaceuticals, LLCNDC labeler code 10572
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 019797
Marketing start
Marketing end
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 10572-302_5d535195-2290-7fa9-e063-6394a90a30d5SPL ID 5d535195-2290-7fa9-e063-6394a90a30d5
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

N410572030201 followed by a unit qualifier and the quantity

Package 10572-0302-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 10572-302

What is NDC 10572-302?
10572-302 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 Affordable Pharmaceuticals, LLC. 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?
Affordable Pharmaceuticals, LLC, NDC labeler code 10572. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloridepolyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloridePolyethylene glycol 3350 420 g/4L + 3 more ingredientsPowder, For solutionOralWilshire Pharmaceuticals, Inc.52536-30252536-0302-01

Other NDCs under NDA 019797

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 019797
ProductStrengthForm · routeLabelerProduct NDC
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloridepolyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloridePolyethylene glycol 3350 420 g/4L + 3 more ingredientsPowder, For solutionOralWilshire Pharmaceuticals, Inc.52536-302

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