NDC 64380-769

NDC codes

FDA NDC Directory

Product NDC (as listed)64380-769Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64380-0769Add 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
64380-769-21	64380076921	4 L in 1 JUG (64380-769-21)Marketed from Apr 14, 2015

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, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride with Lemon Flavor
Generic name (nonproprietary): polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride with lemon flavor
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: Strides Pharma Science Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204559
Marketing start: Apr 14, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Alkalinizing Activity (Mechanism)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers: Product ID 64380-769_7aacd3f0-4851-4b3b-a954-9b4e8afed7b0SPL ID 7aacd3f0-4851-4b3b-a954-9b4e8afed7b0SPL set ID 37c111ec-5b62-42b9-bbb2-3b0c530e34c9RxCUI 801054UNII 451W47IQ8X, 8MDF5V39QO, G2M7P15E5P, 660YQ98I10UPC 0364380768210, 0364380770213
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

N464380076921 followed by a unit qualifier and the quantity

Package 64380-0769-21. 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 1, 2025.

Indications (excerpt from the label)

Polyethylene glycol 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 Polyethylene glycol 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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204559

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

FDA NDC Directory listings under ANDA 204559
Product	Strength	Form · route	Labeler	Product NDC
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Unflavored	Polyethylene glycol 3350 420 g/4L + 3 more ingredients	Powder, For solutionOral	Strides Pharma Science Limited	64380-768
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride with Orange Flavor	Polyethylene glycol 3350 420 g/4L + 3 more ingredients	Powder, For solutionOral	Strides Pharma Science Limited	64380-770

Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride with Lemon Flavor NDC 64380-769