Trilyte NDC 84386-013

NDC codes

FDA NDC Directory

Product NDC (as listed)84386-013Labeler and product segments. Claims need a package NDC.

Product NDC at billing width84386-0013Add 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
84386-013-04	84386001304	4 L in 1 BOTTLE (84386-013-04)Marketed from Apr 14, 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): Trilyte
Generic name (nonproprietary): polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride
Active ingredients: Polyethylene glycol 3350 — 420 g/4LSodium bicarbonate — 5.72 g/4LSodium chloride — 11.2 g/4LPotassium chloride — 1.48 g/4L
Dosage form: Powder, For solution
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076491
Marketing start: Apr 14, 2026
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 84386-013_79f5e596-8d51-4227-afcc-f5e341150957SPL ID 79f5e596-8d51-4227-afcc-f5e341150957SPL set ID 79f5e596-8d51-4227-afcc-f5e341150957RxCUI 801054, 904158UNII G2M7P15E5P, 8MDF5V39QO, 451W47IQ8X, 660YQ98I10
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

N484386001304 followed by a unit qualifier and the quantity

Package 84386-0013-04. 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 Apr 15, 2026.

Indications (excerpt from the label)

TRILYTE is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. TRILYTE 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.

Full label on DailyMed (opens in a new tab)