Over-the-counter drug · NDA
MiraLAX (polyethylene glycol 3350) NDC 11523-7268
Polyethylene glycol 3350 17 g/17g · Powder, For solution · Oral · Bayer HealthCare LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11523-7268-3 | 11523726803 | 10 PACKET in 1 CARTON (11523-7268-3) / 17 g in 1 PACKETMarketed from Feb 1, 2007 | |
| 11523-7268-4 | 11523726804 | 765 g in 1 BOTTLE, PLASTIC (11523-7268-4)Marketed from Feb 1, 2007 | |
| 11523-7268-5 | 11523726805 | 850 g in 1 BOTTLE, PLASTIC (11523-7268-5)Marketed from May 30, 2025 | |
| 11523-7268-8 | 11523726808 | 24 PACKET in 1 CARTON (11523-7268-8) / 17 g in 1 PACKETMarketed from Feb 1, 2007 | |
| 11523-7268-9 | 11523726809 | 20 POUCH in 1 CARTON (11523-7268-9) / 17 g in 1 POUCHMarketed from Feb 1, 2007 |
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)
- MiraLAX
- Generic name (nonproprietary)
- polyethylene glycol 3350
- Active ingredients
- Polyethylene glycol 3350 — 17 g/17g
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Bayer HealthCare LLC.
- 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 11523-7268_51040c1b-71bf-bb83-e063-6294a90aca4eSPL ID 51040c1b-71bf-bb83-e063-6294a90aca4eSPL set ID d69ce3d4-7ca4-4fe3-b49e-6655e48d6963RxCUI 876193, 876195UNII G2M7P15E5PUPC 0041100820716, 0041100564542
- 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
N411523726803followed by a unit qualifier and the quantityPackage 11523-7268-03. 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.