Gavilyte G Tm NDC 43386-090

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-090Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0090Add 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
43386-090-19	43386009019	274.31 g in 1 BOTTLE (43386-090-19)Marketed from Jun 1, 2009

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): Gavilyte G TmSuffix: TM
Generic name (nonproprietary): polyethylene glycol-3350 and electrolytes
Active ingredients: Polyethylene glycol 3350 — 236 g/274.31gSodium sulfate anhydrous — 22.74 g/274.31gSodium bicarbonate — 6.74 g/274.31gSodium chloride — 5.86 g/274.31gPotassium chloride — 2.97 g/274.31g
Dosage form: Powder, For solution
Route: Oral
Labeler: Lupin Pharmaceuticals,Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090231
Marketing start: Jun 1, 2009
Listing expires: Dec 31, 2026
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 43386-090_896fc5ca-9a67-47c1-a317-f8dd4a3654c8SPL ID 896fc5ca-9a67-47c1-a317-f8dd4a3654c8SPL set ID 3978822b-6473-4072-9f80-20ceb9bea355RxCUI 966920, 967012UNII G2M7P15E5P, 36KCS0R750, 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

N443386009019 followed by a unit qualifier and the quantity

Package 43386-0090-19. 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 10, 2025.

Indications (excerpt from the label)

GaviLyte-G 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 ) GaviLyte-G 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 090231

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

FDA NDC Directory listings under ANDA 090231
Product	Strength	Form · route	Labeler	Product NDC
Polyethylene Glycol-3350 And Electrolytes	Polyethylene glycol 3350 236 g/274.31g + 4 more ingredients	Powder, For solutionOral	Novel Laboratories, Inc.	40032-090