Over-the-counter drug · ANDA
Topcare ClearLax (Polyethylene glycol 3350) NDC 36800-306
Polyethylene glycol 3350 17 g/17g · Powder, For solution · Oral · Topco Associates LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)36800-306Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0306Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-306-01 | 3680003060136800030601 | 119 g in 1 BOTTLE (36800-306-01)Marketed from Oct 7, 2009 | |
| 36800-306-02 | 3680003060236800030602 | 238 g in 1 BOTTLE (36800-306-02)Marketed from Oct 7, 2009 | |
| 36800-306-03 | 3680003060336800030603 | 507 g in 1 BOTTLE (36800-306-03)Marketed from Oct 7, 2009 | |
| 36800-306-09 | 3680003060936800030609 | 765 g in 1 BOTTLE (36800-306-09)Marketed from Sep 26, 2022 | |
| 36800-306-19 | 3680003061936800030619 | 595 g in 1 BOTTLE (36800-306-19)Marketed from Aug 21, 2013 | |
| 36800-306-20 | 3680003062036800030620 | 2 BOTTLE in 1 PACKAGE (36800-306-20) / 850 g in 1 BOTTLEMarketed from Mar 18, 2020 |
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)
- Topcare ClearLax
- Generic name (nonproprietary)
- polyethylene glycol 3350
- Active ingredients
- Polyethylene glycol 3350 — 17 g/17g
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Topco Associates LLCNDC labeler code 36800
- 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 36800-306_05d0b5e4-4bde-4c30-8742-f8e7f8e5859cSPL ID 05d0b5e4-4bde-4c30-8742-f8e7f8e5859cSPL set ID 03291fd3-7b64-4b79-ad84-e1b9b30a6b03RxCUI 876193, 880407UNII 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
N436800030601followed by a unit qualifier and the quantityPackage 36800-0306-01. 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)
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 36800-306
- What is NDC 36800-306?
- 36800-306 is the product NDC for Topcare ClearLax (polyethylene glycol 3350), Polyethylene glycol 3350 17 g/17g powder, for solution, listed with the FDA by Topco Associates LLC. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Topcare ClearLax (Polyethylene Glycol 3350).
- What is the active ingredient?
- Polyethylene glycol 3350.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Topcare ClearLax?
- 1 other product NDC are listed under this name. See all Topcare ClearLax NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Topcare ClearLax products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Topcare ClearLaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Topco Associates LLC | 76162-119 | 76162-0119-02 |
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 |
|---|---|---|---|---|
| dg health clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Dolgencorp, LLC | 55910-306 |
| good neighbor pharmacy clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Amerisource Bergen | 46122-805 |
| equaline clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | United Natural Foods, Inc. dba UNFI | 41163-306 |
| Members Mark clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Sam's West Inc | 68196-306 |
| berkley and jensen clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | BJWC | 68391-306 |
| clear laxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Meijer Distribution Inc | 41250-306 |
| MiraLAX Orange Flavorpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Bayer HealthCare LLC. | 11523-0122 |
| Good Neighbor Pharmacy ClearLaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Amerisource Bergen | 46122-014 |
| Exchange Select ClearLaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Army & Air Force Exchange Service | 55301-306 |
| Good Sense Clear Laxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Preferred Pharmaceuticals Inc. | 68788-8795 |
| kirkland signature laxaclear original prescription strengthpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Costco Wholesale Company | 63981-306 |
| purelaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | CVS Pharmacy | 59779-306 |
| gentle laxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Kroger Company | 30142-306 |
| Topcare ClearLaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Topco Associates LLC | 76162-119 |
| rugby PEG 3350polyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Bryant Ranch Prepack | 72162-2155 |
| signature care clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Safeway | 21130-847 |
| purelaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | CVS Pharmacy | 69842-458 |
| Polyethylene Glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Bryant Ranch Prepack | 72162-2172 |
| Clearlaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Amazon.com Services LLC | 72288-471 |
| Gentlelaxpolyethylene glycol 3350 | Polyethylene glycol 3350 17 g/17g | Powder, For solutionOral | Kroger Company | 30142-504 |
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