Prescription drug · NDA
GoLYTELY NDC 52268-100
Polyethylene glycol 3350 236 g/4L + 4 more ingredients · Powder, For solution · Oral · Braintree Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52268-100-01 | 52268010001 | 4 L in 1 BOTTLE, PLASTIC (52268-100-01)Marketed from Jul 13, 1984 |
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)
- GoLYTELY
- Generic name (nonproprietary)
- polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride
- Active ingredients
- Polyethylene glycol 3350 — 236 g/4LSodium sulfate anhydrous — 22.74 g/4LSodium bicarbonate — 6.74 g/4LSodium chloride — 5.86 g/4LPotassium chloride — 2.97 g/4L
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Braintree Laboratories, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019011
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)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)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)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Potassium Compounds (Chemical structure)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 52268-100_c3649858-77b7-2295-e053-2995a90a048fSPL ID c3649858-77b7-2295-e053-2995a90a048fSPL set ID 57d22b0b-1ae0-4203-babc-f3bac17bd1c9RxCUI 966916, 966920, 966922, 1870431UNII 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
N452268010001followed by a unit qualifier and the quantityPackage 52268-0100-01. 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)
GoLYTELY is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults. GoLYTELY 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 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 019011
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 |
|---|---|---|---|---|
| PEG 3350 and Electrolytespolyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride | Polyethylene glycol 3350 236 g/4L + 4 more ingredients | Powder, For solutionOral | Wilshire Pharmaceuticals, Inc. | 52536-236 |
| PEG 3350 and Electrolytespolyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride | Polyethylene glycol 3350 236 g/4L + 4 more ingredients | Powder, For solutionOral | A-S Medication Solutions | 50090-8020 |
| PEG-3350 and Electrolytespolyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride | Polyethylene glycol 3350 236 g/4L + 4 more ingredients | Powder, For solutionOral | Affordable Pharmaceuticals, LLC | 10572-100 |
| PEG-3350 and Electrolytespolyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride | Polyethylene glycol 3350 236 g/4L + 4 more ingredients | Powder, For solutionOral | A-S Medication Solutions | 50090-6521 |
| GoLYTELYpolyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride | Polyethylene glycol 3350 236 g/4L + 4 more ingredients | Powder, For solutionOral | Azurity Pharmaceuticals, Inc. | 24338-236 |