Over-the-counter drug · ANDA
Gavilax (polyethylene glycol 3350) NDC 68788-7508
Polyethylene glycol 3350 17 g/17g · Powder, For solution · Oral · Preferred Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-7508-2 | 68788750802 | 238 g in 1 BOTTLE (68788-7508-2)Marketed from Oct 28, 2019 |
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
- 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 68788-7508_f868cc44-d891-42de-8c52-78e9d85651b2SPL ID f868cc44-d891-42de-8c52-78e9d85651b2SPL set ID 21654def-5ae0-422d-961b-1fe2456af00aRxCUI 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
N468788750802followed by a unit qualifier and the quantityPackage 68788-7508-02. 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: • 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.
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 | 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 |