Over-the-counter drug · ANDA
Clearlax (polyethylene glycol 3350) NDC 70677-1068
Polyethylene glycol 3350 17 g/17g · Powder, For solution · Oral · STRATEGIC SOURCING SERVICES LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70677-1068-1 | 70677106801 | 238 g in 1 BOTTLE (70677-1068-1)Marketed from Aug 1, 2023 |
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)
- Clearlax
- 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
- Marketing end
- Other FDA classes
- Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 70677-1068_374e2998-0c02-c804-e063-6394a90a67c4SPL ID 374e2998-0c02-c804-e063-6394a90a67c4SPL set ID 041157b8-476c-e7d2-e063-6394a90ac3a0RxCUI 876193, 880407UNII 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
N470677106801followed by a unit qualifier and the quantityPackage 70677-1068-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 | Geri-Care Pharmaceutical Corp | 57896-489 |
| 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 |
| 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 |