What is NDC 43386-050?

43386-050 is the product NDC for Gavilyte-N, Polyethylene glycol 3350 420 g/438.4g + 3 more ingredients powder, for solution, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Gavilyte-N (Polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate).

What is the active ingredient?

Polyethylene glycol 3350, Sodium chloride, Sodium bicarbonate, Potassium chloride.

Lupin Pharmaceuticals,Inc., NDC labeler code 43386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Gavilyte-N?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Gavilyte-N NDC 43386-050 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-050Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0050Add 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
43386-050-19	43386005019	438.4 g in 1 BOTTLE (43386-050-19)Marketed from May 28, 2009 · Sample package

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-N
Generic name (nonproprietary): polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate
Active ingredients: Polyethylene glycol 3350 — 420 g/438.4gSodium chloride — 11.2 g/438.4gSodium bicarbonate — 5.72 g/438.4gPotassium chloride — 1.48 g/438.4g
Dosage form: Powder, For solution
Route: Oral
Labeler: Lupin Pharmaceuticals,Inc.NDC labeler code 43386
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090019
Marketing start: May 28, 2009
Listing expires: Dec 31, 2026
Other FDA classes: 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)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Potassium Compounds (Chemical structure)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers: Product ID 43386-050_3839c7fd-e7c4-45c6-ae02-0302b40046b0SPL ID 3839c7fd-e7c4-45c6-ae02-0302b40046b0SPL set ID 27195187-75a3-431f-90d9-84da1b94e849RxCUI 801054, 979099UNII G2M7P15E5P, 451W47IQ8X, 8MDF5V39QO, 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

N443386005019 followed by a unit qualifier and the quantity

Package 43386-0050-19. 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-N 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 ) GaviLyte-N 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)

About NDC 43386-050

What is NDC 43386-050?: 43386-050 is the product NDC for Gavilyte-N, Polyethylene glycol 3350 420 g/438.4g + 3 more ingredients powder, for solution, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Gavilyte-N (Polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate).
What is the active ingredient?: Polyethylene glycol 3350, Sodium chloride, Sodium bicarbonate, Potassium chloride.
Who is the labeler?: Lupin Pharmaceuticals,Inc., NDC labeler code 43386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Gavilyte-N?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.