Over-the-counter drug · ANDA
smooth lax (Polyethylene glycol 3350) NDC 0363-0306
Polyethylene glycol 3350 17 g/17g · Powder, For solution · Oral · Walgreen Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-0306-02 | 0036303060200363030602 | 238 g in 1 BOTTLE (0363-0306-02)Marketed from Oct 9, 2009 | |
| 0363-0306-03 | 0036303060300363030603 | 510 g in 1 BOTTLE (0363-0306-03)Marketed from Oct 9, 2009 | |
| 0363-0306-09 | 0036303060900363030609 | 765 g in 1 BOTTLE (0363-0306-09)Marketed from Apr 10, 2015 | |
| 0363-0306-19 | 0036303061900363030619 | 595 g in 1 BOTTLE (0363-0306-19)Marketed from Dec 14, 2024 | |
| 0363-0306-52 | 0036303065200363030652 | 10 POUCH in 1 CARTON (0363-0306-52) / 17 g in 1 POUCH (0363-0306-00)Marketed from Apr 27, 2010 | |
| 0363-0306-60 | 0036303066000363030660 | 20 POUCH in 1 CARTON (0363-0306-60) / 17 g in 1 POUCH (0363-0306-00)Marketed from May 28, 2019 |
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)
- smooth lax
- Generic name (nonproprietary)
- polyethylene glycol 3350
- Active ingredients
- Polyethylene glycol 3350 — 17 g/17g
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Walgreen CompanyNDC labeler code 0363
- 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 0363-0306_c677ed05-f149-4430-baba-d65b43cd1828SPL ID c677ed05-f149-4430-baba-d65b43cd1828SPL set ID 3027af65-2f7f-472d-83f5-254d5d75013cRxCUI 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
N400363030602followed by a unit qualifier and the quantityPackage 00363-0306-02. 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 0363-0306
- What is NDC 0363-0306?
- 0363-0306 is the product NDC for smooth lax (polyethylene glycol 3350), Polyethylene glycol 3350 17 g/17g powder, for solution, listed with the FDA by Walgreen Company. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- smooth lax (Polyethylene Glycol 3350).
- What is the active ingredient?
- Polyethylene glycol 3350.
- Who is the labeler?
- Walgreen Company, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for smooth lax?
- 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 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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