Over-the-counter drug · ANDA
Polyethylene Glycol 3350 NF (Polyethylene glycol 3350) NDC 11534-180
Polyethylene glycol 3350 17 g/17g · Powder, For solution · Oral · SUNRISE PHARMACEUTICAL, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11534-180-19 | 1153401801911534018019 | 119 g in 1 BOTTLE (11534-180-19)Marketed from Jun 13, 2017 | |
| 11534-180-28 | 1153401802811534018028 | 238 g in 1 BOTTLE (11534-180-28)Marketed from Jun 13, 2017 | |
| 11534-180-50 | 1153401805011534018050 | 510 g in 1 BOTTLE (11534-180-50)Marketed from Jun 13, 2017 |
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 NF
- Generic name (nonproprietary)
- polyethylene glycol 3350
- Active ingredients
- Polyethylene glycol 3350 — 17 g/17g
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- SUNRISE PHARMACEUTICAL, INCNDC labeler code 11534
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206105
- Marketing start
- Listing expires
- Other FDA classes
- Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 11534-180_020b7f87-0f3a-4223-a402-dea12a6c53d2SPL ID 020b7f87-0f3a-4223-a402-dea12a6c53d2SPL set ID ce5197a1-2677-4ffb-aef2-9221b28ebd23RxCUI 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
N411534018019followed by a unit qualifier and the quantityPackage 11534-0180-19. 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 11534-180
- What is NDC 11534-180?
- 11534-180 is the product NDC for Polyethylene Glycol 3350 NF (polyethylene glycol 3350), Polyethylene glycol 3350 17 g/17g powder, for solution, listed with the FDA by SUNRISE PHARMACEUTICAL, INC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Polyethylene Glycol 3350 NF (Polyethylene glycol 3350).
- What is the active ingredient?
- Polyethylene glycol 3350.
- Who is the labeler?
- SUNRISE PHARMACEUTICAL, INC, NDC labeler code 11534. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Polyethylene Glycol 3350 NF?
- 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.