Over-the-counter drug · NDA
MiraLAX (polyethylene glycol 3350) NDC 76420-489
Polyethylene glycol 3350 17 g/17g · Powder, For solution · Oral · ASCLEMED USA INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-489-10 | 76420048910 | 10 PACKET in 1 CARTON (76420-489-10) / 17 g in 1 PACKETMarketed from Oct 14, 2025 | |
| 76420-489-20 | 76420048920 | 20 POUCH in 1 CARTON (76420-489-20) / 17 g in 1 POUCHMarketed from Oct 14, 2025 | |
| 76420-489-24 | 76420048924 | 24 PACKET in 1 CARTON (76420-489-24) / 17 g in 1 PACKETMarketed from Oct 14, 2025 | |
| 76420-489-77 | 76420048977 | 765 g in 1 BOTTLE, PLASTIC (76420-489-77)Marketed from Oct 14, 2025 | |
| 76420-489-85 | 76420048985 | 850 g in 1 BOTTLE, PLASTIC (76420-489-85)Marketed from Oct 14, 2025 |
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)
- MiraLAX
- Generic name (nonproprietary)
- polyethylene glycol 3350
- Active ingredients
- Polyethylene glycol 3350 — 17 g/17g
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- ASCLEMED USA INC.
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022015
- Marketing start
- Listing expires
- Other FDA classes
- Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 76420-489_411a7a72-348c-4e5b-e063-6294a90a6c7eSPL ID 411a7a72-348c-4e5b-e063-6294a90a6c7eSPL set ID e652042f-3707-4bf6-831d-d806638b7d85RxCUI 876193, 876195UNII 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
N476420048910followed by a unit qualifier and the quantityPackage 76420-0489-10. 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 NDA 022015
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 |
|---|---|---|---|---|
| MiraLAXpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Bayer HealthCare LLC. | 11523-7268 |
| MiraLAXpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Bayer HealthCare LLC. | 11523-4357 |
| MiraLAXpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Cardinal Health 107, LLC | 55154-5035 |