Gavilax (polyethylene glycol 3350) NDC 63187-368

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-368Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0368Add 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
63187-368-23	63187036823	238 g in 1 BOTTLE (63187-368-23)Marketed from Sep 1, 2016

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): Gavilax
Generic name (nonproprietary): polyethylene glycol 3350
Active ingredients: Polyethylene glycol 3350 — 17 g/17g
Dosage form: Powder, For solution
Route: Oral
Labeler: Proficient Rx LP
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091077
Marketing start: Oct 9, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers: Product ID 63187-368_f28b44fb-7018-43ee-9d1b-c8d6bdcb7894SPL ID f28b44fb-7018-43ee-9d1b-c8d6bdcb7894SPL set ID 199d6173-3fad-49e4-88fe-bde7223ed4c3RxCUI 876193, 876214UNII G2M7P15E5PUPC 0363187368234
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

N463187036823 followed by a unit qualifier and the quantity

Package 63187-0368-23. 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 Jun 1, 2022.

Indications (excerpt from the label)

Directions • do not take more than directed unless advised by your doctor • the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line. • adults and children 17 years of age and older: • fill to top of line in cap which is marked to indicate the correct dose (17 g) • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink • use once a day • use no more than 7 days • children 16 years of age or under: ask a doctor Other Information • store at 20°- 25°C (68°– 77°F) • tamper-evident: do not use if printed foil seal under cap is missing, open or broken

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091077

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

FDA NDC Directory listings under ANDA 091077
Product	Strength	Form · route	Labeler	Product NDC
Gavilaxpolyethylene glycol 3350	Polyethylene glycol 3350 17 g/17g	Powder, For solutionOral	A-S Medication Solutions	50090-5310
Polyethylene Glycol	Polyethylene glycol 3350 17 g/17g	Powder, For suspensionOral	BluePoint Laboratories	68001-505
Gavilaxpolyethylene glycol 3350	Polyethylene glycol 3350 17 g/17g	Powder, For solutionOral	Preferred Pharmaceuticals, Inc.	68788-7508
Gavilaxpolyethylene glycol 3350	Polyethylene glycol 3350 17 g/17g	Powder, For solutionOral	Lupin Pharmaceuticals,Inc.	43386-312
Gavilaxpolyethylene glycol 3350	Polyethylene glycol 3350 17 g/17g	Powder, For solutionOral	Atlantic Biologicals Corp.	17856-0310
Gavilaxpolyethylene glycol 3350	Polyethylene glycol 3350 17 g/17g	Powder, For solutionOral	ATLANTIC BIOLOGICALS CORP.	17856-0312