Over-the-counter drug · ANDA
Polyethylene Glycol 3350 NDC 57896-489
Polyethylene glycol 3350 17 g/17g · Powder, For solution · Oral · Geri-Care Pharmaceutical Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57896-489-14 | 57896048914 | 238 g in 1 BOTTLE (57896-489-14)Marketed from Jul 1, 2016 | |
| 57896-489-30 | 57896048930 | 510 g in 1 BOTTLE (57896-489-30)Marketed from Jul 1, 2016 |
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 090812
- Marketing start
- Listing expires
- Other FDA classes
- Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 57896-489_ee3ad47b-8219-3bc4-e053-2a95a90af736SPL ID ee3ad47b-8219-3bc4-e053-2a95a90af736SPL set ID f4c7eb80-d8d5-406d-90d0-9d17914d71f2RxCUI 876193UNII 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
N457896048914followed by a unit qualifier and the quantityPackage 57896-0489-14. 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)
Uses 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 090812
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 | Bryant Ranch Prepack | 72162-2180 |
| Polyethylene Glycol 3350, NF Powder for Solution, Laxative | Polyethylene glycol 3350 17 g/d | Powder, For solutionOral | Pharmaceutica North America, Inc. | 45861-083 |
| Clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | STRATEGIC SOURCING SERVICES LLC | 70677-1068 |
| EasyLAXpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | VALU MERCHANDISERS COMPANY | 63941-489 |
| Polyethylene Glycol 3350, NF Powder for Solution, Laxative | Polyethylene glycol 3350 17 g/d | Powder, For solutionOral | LGM PHARMA SOLUTIONS, LLC | 79739-7116 |