Over-the-counter drug · ANDA
Gavilax (Polyethylene glycol 3350) NDC 43386-312
Polyethylene glycol 3350 17 g/17g · Powder, For solution · Oral · Lupin Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43386-312-08 | 4338603120843386031208 | 238 g in 1 BOTTLE (43386-312-08)Marketed from Oct 9, 2009 · Sample package | |
| 43386-312-14 | 4338603121443386031214 | 510 g in 1 BOTTLE (43386-312-14)Marketed from Oct 9, 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)
- Gavilax
- Generic name (nonproprietary)
- polyethylene glycol 3350
- Active ingredients
- Polyethylene glycol 3350 — 17 g/17g
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals,Inc.NDC labeler code 43386
- 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 43386-312_ced29c35-5d51-4eb1-8119-1c988d29a592SPL ID ced29c35-5d51-4eb1-8119-1c988d29a592SPL set ID 19672e23-1606-497e-a112-939af33af195RxCUI 876193, 876214UNII G2M7P15E5PUPC 0343386312085
- 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
N443386031208followed by a unit qualifier and the quantityPackage 43386-0312-08. 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.
About NDC 43386-312
- What is NDC 43386-312?
- 43386-312 is the product NDC for Gavilax (polyethylene glycol 3350), Polyethylene glycol 3350 17 g/17g powder, for solution, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gavilax (Polyethylene Glycol 3350).
- What is the active ingredient?
- Polyethylene glycol 3350.
- 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 Gavilax?
- 5 other product NDCs are listed under this name. See all Gavilax NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gavilax products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gavilaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | ATLANTIC BIOLOGICALS CORP. | 17856-0312 | 17856-0312-0117856-0312-0217856-0312-03+6 more |
| Gavilaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Atlantic Biologicals Corp. | 17856-0310 | 17856-0310-0117856-0310-02 |
| Gavilaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | A-S Medication Solutions | 50090-5310 | 50090-5310-00 |
| Gavilaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Proficient Rx LP | 63187-368 | 63187-0368-23 |
| Gavilaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Preferred Pharmaceuticals, Inc. | 68788-7508 | 68788-7508-02 |
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 | Atlantic Biologicals Corp. | 17856-0310 |
| Gavilaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | ATLANTIC BIOLOGICALS CORP. | 17856-0312 |
| Gavilaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | A-S Medication Solutions | 50090-5310 |
| 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 |
| Polyethylene Glycol | Polyethylene glycol 3350 17 g/17g | Powder, For suspensionOral | BluePoint Laboratories | 68001-505 |