Over-the-counter drug · ANDA
Peg3350 (Polyethylene glycol 3350) NDC 0904-7534
Polyethylene glycol 3350 17 g/17g · Powder, For solution · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7534-26 | 00904753426 | 15 PACKET in 1 CARTON (0904-7534-26) / 17 g in 1 PACKETMarketed from Aug 28, 2026 | |
| 0904-7534-86 | 00904753486 | 17 g in 1 PACKET (0904-7534-86)Marketed from Aug 28, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Peg3350
- Generic name (nonproprietary)
- polyethylene glycol 3350
- Active ingredients
- Polyethylene glycol 3350 — 17 g/17g
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217505
- Marketing start
- Listing expires
- Other FDA classes
- Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 0904-7534_3e0f5355-f066-4626-8951-ee9aa0ff7c37SPL ID 3e0f5355-f066-4626-8951-ee9aa0ff7c37SPL set ID 161629f6-6193-4712-bba7-7d5b174a9338RxCUI 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
N400904753426followed by a unit qualifier and the quantityPackage 00904-7534-26. 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.
About NDC 0904-7534
- What is NDC 0904-7534?
- 0904-7534 is the product NDC for Peg3350 (polyethylene glycol 3350), Polyethylene glycol 3350 17 g/17g powder, for solution, listed with the FDA by Major Pharmaceuticals. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Peg3350 (Polyethylene Glycol 3350).
- What is the active ingredient?
- Polyethylene glycol 3350.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Peg3350?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 217505
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 | L.N.K. International, Inc. | 50844-772 |