Over-the-counter drug · ANDA
Polyethylene Glycol 3350 NDC 84386-125
Polyethylene glycol 3350 17 g/17g · Powder, For solution · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84386-125-08 | 84386012508 | 119 g in 1 BOTTLE, PLASTIC (84386-125-08)Marketed from Jan 7, 2026 | |
| 84386-125-14 | 84386012514 | 14 PACKET in 1 CARTON (84386-125-14) / 17 g in 1 PACKETMarketed from Jan 7, 2026 | |
| 84386-125-24 | 84386012524 | 238 g in 1 BOTTLE, PLASTIC (84386-125-24)Marketed from Jan 7, 2026 | |
| 84386-125-54 | 84386012554 | 510 g in 1 BOTTLE, PLASTIC (84386-125-54)Marketed from Jan 7, 2026 |
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
- Labeler
- Aurobindo Pharma Limited
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209017
- Marketing start
- Listing expires
- Other FDA classes
- Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 84386-125_0ae015fc-a1b3-4ace-b5de-85e07b154f5cSPL ID 0ae015fc-a1b3-4ace-b5de-85e07b154f5cSPL set ID b51f2223-8266-4d6c-bf32-58e53e73b54dRxCUI 876193UNII G2M7P15E5PUPC 0384386125084
- 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
N484386012508followed by a unit qualifier and the quantityPackage 84386-0125-08. 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 209017
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 |
|---|---|---|---|---|
| Comfortlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Family Dollar Stores, LLC | 55319-056 |
| 365 WHOLE FOODS MARKET Polyethylene Glycol 3350polyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Whole Foods Market, Inc. | 42681-0059 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Aurohealth LLC | 58602-805 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0699 |