Over-the-counter drug · ANDA
Polyethylene Glycol NDC 68001-505
Polyethylene glycol 3350 17 g/17g · Powder, For suspension · Oral · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-505-55 | 6800105055568001050555 | 238 g in 1 BOTTLE (68001-505-55)Marketed from Jun 18, 2021 | |
| 68001-505-69 | 6800105056968001050569 | 510 g in 1 BOTTLE (68001-505-69)Marketed from Jun 18, 2021 |
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)
- Polyethylene Glycol
- Generic name (nonproprietary)
- polyethylene glycol
- Active ingredients
- Polyethylene glycol 3350 — 17 g/17g
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- BluePoint LaboratoriesNDC labeler code 68001
- 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 68001-505_cc6e2865-14e2-1ac7-e053-2a95a90acbc0SPL ID cc6e2865-14e2-1ac7-e053-2a95a90acbc0SPL set ID c4cae70c-68da-0bbc-e053-2a95a90a395aUNII 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
N468001050555followed by a unit qualifier and the quantityPackage 68001-0505-55. 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)
USE Relieves occasional constipation (irregularity) Generally produces a bowel movement in 1 to 3 days
Excerpt only. Read the full label for complete information.
About NDC 68001-505
- What is NDC 68001-505?
- 68001-505 is the product NDC for Polyethylene Glycol, Polyethylene glycol 3350 17 g/17g powder, for suspension, listed with the FDA by BluePoint Laboratories. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Polyethylene Glycol.
- What is the active ingredient?
- Polyethylene glycol 3350.
- Who is the labeler?
- BluePoint Laboratories, NDC labeler code 68001. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Polyethylene Glycol?
- 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.
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 | Lupin Pharmaceuticals,Inc. | 43386-312 |
| 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 |