Over-the-counter drug · ANDA
rugby PEG 3350 (Polyethylene glycol 3350) NDC 0536-1052
Polyethylene glycol 3350 17 g/17g · Powder, For solution · Oral · Rugby Laboratories
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0536-1052Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00536-1052Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-1052-24 | 00536105224 | 238 g in 1 BOTTLE (0536-1052-24)Marketed from Jan 5, 2015 | |
| 0536-1052-27 | 00536105227 | 510 g in 1 BOTTLE (0536-1052-27)Marketed from Jan 5, 2015 | |
| 0536-1052-60 | 00536105260 | 119 g in 1 BOTTLE (0536-1052-60)Marketed from Jul 25, 2024 | |
| 0536-1052-84 | 00536105284 | 850 g in 1 BOTTLE (0536-1052-84)Marketed from Jan 5, 2015 |
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)
- rugby PEG 3350
- Generic name (nonproprietary)
- polyethylene glycol 3350
- Active ingredients
- Polyethylene glycol 3350 — 17 g/17g
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Rugby LaboratoriesNDC labeler code 0536
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090685
- Marketing start
- Listing expires
- Other FDA classes
- Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 0536-1052_103edafc-0a15-4257-9dc4-f1c9938342f1SPL ID 103edafc-0a15-4257-9dc4-f1c9938342f1
- 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
N400536105224followed by a unit qualifier and the quantityPackage 00536-1052-24. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0536-1052
- What is NDC 0536-1052?
- 0536-1052 is the product NDC for rugby PEG 3350 (polyethylene glycol 3350), Polyethylene glycol 3350 17 g/17g powder, for solution, listed with the FDA by Rugby Laboratories. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- rugby PEG 3350 (Polyethylene glycol 3350).
- What is the active ingredient?
- Polyethylene glycol 3350.
- Who is the labeler?
- Rugby Laboratories, NDC labeler code 0536. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for rugby PEG 3350?
- 1 other product NDC are listed under this name. See all rugby PEG 3350 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other rugby PEG 3350 products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| rugby PEG 3350polyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Bryant Ranch Prepack | 72162-2155 | 72162-2155-0272162-2155-04 |
Other NDCs under ANDA 090685
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 |
|---|---|---|---|---|
| basic care clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Amazon.com Services LLC | 72288-020 |
| basic care clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Amazon.com Services LLC | 72288-499 |
| berkley and jensen clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | BJWC | 68391-306 |
| care one clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | American Sales Company | 41520-306 |
| careone clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Retail Business Services, LLC | 72476-723 |
| clear laxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | H E B | 37808-306 |
| clear laxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Meijer Distribution Inc | 41250-306 |
| clear laxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | HyVee Inc | 42507-306 |
| Clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Safeway | 21130-637 |
| clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Publix Super Markets Inc | 56062-306 |
| clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | H E B | 59640-797 |
| Clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Amazon.com Services LLC | 72288-033 |
| Clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Amazon.com Services LLC | 72288-471 |
| clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Meijer, Inc. | 79481-0090 |
| dg health clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Dolgencorp, LLC | 55910-306 |
| dg health clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Dolgencorp Inc | 55910-846 |
| Dulcolaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | PowderOral | Chattem, Inc. | 41167-0223 |
| equaline clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | United Natural Foods, Inc. dba UNFI | 41163-306 |
| equate clear laxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Wal-Mart Stores Inc | 49035-306 |
| Equate ClearLAXpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | WALMART INC. | 79903-114 |
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