NDC 45861-083

NDC codes

FDA NDC Directory

Product NDC (as listed)45861-083Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45861-0083Add 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 NDC	11-digit (billing)	Package	Copy
45861-083-05	45861008305	238 d in 1 BOTTLE (45861-083-05)Marketed from Feb 10, 2025
45861-083-06	45861008306	2 BOTTLE in 1 BOX (45861-083-06) / 476 d in 1 BOTTLEMarketed from Feb 10, 2025

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): Polyethylene Glycol 3350, NF Powder for Solution, Laxative
Generic name (nonproprietary): polyethylene glycol 3350, nf powder for solution, laxative
Active ingredients: Polyethylene glycol 3350 — 17 g/d
Dosage form: Powder, For solution
Route: Oral
Labeler: Pharmaceutica North America, Inc.
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090812
Marketing start: Feb 10, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers: Product ID 45861-083_2f83c954-31c2-fa95-e063-6394a90a5861SPL ID 2f83c954-31c2-fa95-e063-6394a90a5861SPL set ID d048111f-8144-4d51-a0c2-a967b2bce455RxCUI 876193UNII G2M7P15E5P
Pharmacologic class: 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

N445861008305 followed by a unit qualifier and the quantity

Package 45861-0083-05. 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 Mar 4, 2025.

Indications (excerpt from the label)

Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090812

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

FDA NDC Directory listings under ANDA 090812
Product	Strength	Form · route	Labeler	Product NDC
Polyethylene Glycol 3350	Polyethylene glycol 3350 17 g/17g	Powder, For solutionOral	Geri-Care Pharmaceutical Corp	57896-489
Polyethylene Glycol 3350	Polyethylene glycol 3350 17 g/17g	Powder, For solutionOral	Bryant Ranch Prepack	72162-2180
Clearlaxpolyethylene glycol 3350	Polyethylene glycol 3350 17 g/17g	Powder, For solutionOral	STRATEGIC SOURCING SERVICES LLC	70677-1068
EasyLAXpolyethylene glycol 3350	Polyethylene glycol 3350 17 g/17g	Powder, For solutionOral	VALU MERCHANDISERS COMPANY	63941-489
Polyethylene Glycol 3350, NF Powder for Solution, Laxative	Polyethylene glycol 3350 17 g/d	Powder, For solutionOral	LGM PHARMA SOLUTIONS, LLC	79739-7116

Polyethylene Glycol 3350, NF Powder for Solution, Laxative NDC 45861-083