Over-the-counter drug · ANDA
Polyethylene Glycol 3350 NDC 83324-002
Polyethylene glycol 3350 17 g/17g · Powder, For solution · Oral · CHAIN DRUG MARKETING ASSOCIATION, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83324-002-08 | 83324000208 | 238 g in 1 BOTTLE (83324-002-08)Marketed from Mar 1, 2024 | |
| 83324-002-16 | 83324000216 | 510 g in 1 BOTTLE (83324-002-16)Marketed from Mar 1, 2024 |
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 3350
- 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 214990
- Marketing start
- Listing expires
- Other FDA classes
- Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 83324-002_148df422-86ec-3bae-e063-6394a90a364eSPL ID 148df422-86ec-3bae-e063-6394a90a364eSPL set ID 901a1918-87bb-47c2-a465-8c468c3a1ee5RxCUI 876193UNII G2M7P15E5PUPC 0635515959811
- 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
N483324000208followed by a unit qualifier and the quantityPackage 83324-0002-08. 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)
Use • relieves occasional constipation (irregularity) • generally produces a bowel movement in 1 to 3 days
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214990
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 |
|---|---|---|---|---|
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Camber Consumer Care Inc | 69230-324 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Preferred Pharmaceuticals Inc. | 68788-8601 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/1 | Powder, For solutionOral | YYBA Corp | 73581-913 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | BluePoint Laboratories | 68001-607 |
| Polyethylene Gycol 3350 | Polyethylene glycol 3350 17 g/g | Powder, For solutionOral | Allegiant Health | 69168-473 |