Over-the-counter drug · ANDA
Gavilax (polyethylene glycol 3350) NDC 17856-0310
Polyethylene glycol 3350 17 g/17g · Powder, For solution · Oral · Atlantic Biologicals Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17856-0310-1 | 17856031001 | 50 CUP, UNIT-DOSE in 1 CASE (17856-0310-1) / 2 g in 1 CUP, UNIT-DOSEMarketed from Jun 1, 2026 | |
| 17856-0310-2 | 17856031002 | 72 POUCH in 1 CASE (17856-0310-2) / 2 g in 1 POUCHMarketed from Mar 3, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Atlantic Biologicals Corp.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091077
- Marketing start
- Listing expires
- Other FDA classes
- Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 17856-0310_536f279a-56fc-0a05-e063-6294a90a2528SPL ID 536f279a-56fc-0a05-e063-6294a90a2528SPL set ID 4c207478-6f0f-c3cf-e063-6394a90aa4f2RxCUI 876193, 876214UNII G2M7P15E5P
- 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
N417856031001followed by a unit qualifier and the quantityPackage 17856-0310-01. 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 .
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: use once a day 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 do not combine with starch-based thickeners used for difficulty swallowing ensure that the powder is fully dissolved before drinking do not drink if there are any clumps do not use more than 7 days children 16 years of age or under: ask a doctor Other Information store at 20°- 25°C (68°…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091077
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 | Proficient Rx LP | 63187-368 |
| 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. | 17856-0312 |