Polyethylene Glycol 3350 and electrolytes - Unflavored NDC 64380-765

NDC codes

FDA NDC Directory

Product NDC (as listed)64380-765Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64380-0765Add 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
64380-765-21	64380076521	4 L in 1 JUG (64380-765-21)Marketed from Jan 10, 2019

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 and electrolytes - Unflavored
Generic name (nonproprietary): polyethylene glycol 3350 and electrolytes - unflavored
Active ingredients: Polyethylene glycol 3350 — 236 g/4LSodium sulfate anhydrous — 22.74 g/4LSodium bicarbonate — 6.74 g/4LSodium chloride — 5.86 g/4LPotassium chlorate — 2.97 g/4L
Dosage form: Powder, For solution
Route: Oral
Labeler: Strides Pharma Science Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204558
Marketing start: Jan 10, 2019
Listing expires: Dec 31, 2027
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 64380-765_d0b5c5be-e56a-4c27-909e-188913075072SPL ID d0b5c5be-e56a-4c27-909e-188913075072SPL set ID 48c741a9-9039-4fdb-a875-86d4ea968282RxCUI 966920UNII 660YQ98I10, 36KCS0R750, G2M7P15E5P, 8MDF5V39QO, 451W47IQ8X, H35KS68EE7UPC 0364380765219, 0364380766216, 0364380767213
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

N464380076521 followed by a unit qualifier and the quantity

Package 64380-0765-21. 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 Sep 5, 2025.

Indications (excerpt from the label)

Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults. (1) Polyethylene Glycol 3350 and electrolytes for oral solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204558

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

FDA NDC Directory listings under ANDA 204558
Product	Strength	Form · route	Labeler	Product NDC
Polyethylene Glycol 3350 and electrolyteswith Orange Flavorpolyethylene glycol 3350 and electrolytes with orange flavor	Polyethylene glycol 3350 236 g/4L + 4 more ingredients	Powder, For solutionOral	Strides Pharma Science Limited	64380-767
Polyethylene Glycol 3350 and electrolytes with Lemon Flavor	Polyethylene glycol 3350 236 g/4L + 4 more ingredients	Powder, For solutionOral	Strides Pharma Science Limited	64380-766