Prescription drug · ANDA
Polyethylene Glycol-3350 And Electrolytes NDC 40032-090
Polyethylene glycol 3350 236 g/274.31g + 4 more ingredients · Powder, For solution · Oral · Novel Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 40032-090-19 | 4003200901940032009019 | 274.31 g in 1 BOTTLE (40032-090-19)Marketed from Jun 1, 2009 |
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 And Electrolytes
- Generic name (nonproprietary)
- polyethylene glycol-3350 and electrolytes
- Active ingredients
- Polyethylene glycol 3350 — 236 g/274.31gSodium sulfate anhydrous — 22.74 g/274.31gSodium bicarbonate — 6.74 g/274.31gSodium chloride — 5.86 g/274.31gPotassium chloride — 2.97 g/274.31g
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Novel Laboratories, Inc.NDC labeler code 40032
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090231
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Potassium Compounds (Chemical structure)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 40032-090_dd003952-2ae1-4c8d-9f2e-8dd6ae470279SPL ID dd003952-2ae1-4c8d-9f2e-8dd6ae470279SPL set ID 29d821ff-389c-41fb-8a27-89bd3f022b82RxCUI 966920UNII G2M7P15E5P, 36KCS0R750, 8MDF5V39QO, 451W47IQ8X, 660YQ98I10
- Pharmacologic class
- Osmotic Laxative; Potassium Salt
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
N440032009019followed by a unit qualifier and the quantityPackage 40032-0090-19. 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)
PEG-3350 and electrolytes for oral solution, USP is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults ( 1 ) PEG-3350 and electrolytes for oral solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.
Excerpt only. Read the full label for complete information.
About NDC 40032-090
- What is NDC 40032-090?
- 40032-090 is the product NDC for Polyethylene Glycol-3350 And Electrolytes, Polyethylene glycol 3350 236 g/274.31g + 4 more ingredients powder, for solution, listed with the FDA by Novel Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Polyethylene Glycol-3350 And Electrolytes.
- What is the active ingredient?
- Polyethylene glycol 3350, Sodium sulfate anhydrous, Sodium bicarbonate, Sodium chloride, Potassium chloride.
- Who is the labeler?
- Novel Laboratories, Inc., NDC labeler code 40032. 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 And Electrolytes?
- 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 090231
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 |
|---|---|---|---|---|
| Gavilyte G Tmpolyethylene glycol-3350 and electrolytes | Polyethylene glycol 3350 236 g/274.31g + 4 more ingredients | Powder, For solutionOral | Lupin Pharmaceuticals,Inc. | 43386-090 |