What is NDC 0363-1323?

0363-1323 is the product NDC for smoothlax (polyethylene glycol 3350), Polyethylene glycol 3350 17 g/17g powder, for solution, listed with the FDA by Walgreen Company. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

smoothlax (Polyethylene Glycol 3350).

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 smoothlax?

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.

smoothlax NDC 0363-1323 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0363-1323Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00363-1323Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0363-1323-02	00363132302	238 g in 1 BOTTLE (0363-1323-02)Marketed from Mar 12, 2024
0363-1323-03	00363132303	510 g in 1 BOTTLE (0363-1323-03)Marketed from Feb 10, 2023

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): smoothlax
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: Feb 10, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers: Product ID 0363-1323_fbec76fb-d6b3-42eb-ac3b-980ef6ac4561SPL ID fbec76fb-d6b3-42eb-ac3b-980ef6ac4561SPL set ID aeb5c32c-443e-4ea3-8e96-fed38225fdf3RxCUI 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

N400363132302 followed by a unit qualifier and the quantity

Package 00363-1323-02. 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 Mar 12, 2024.

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.

Full label on DailyMed (opens in a new tab)

About NDC 0363-1323

What is NDC 0363-1323?: 0363-1323 is the product NDC for smoothlax (polyethylene glycol 3350), Polyethylene glycol 3350 17 g/17g powder, for solution, listed with the FDA by Walgreen Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: smoothlax (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 smoothlax?: 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.

FDA NDC Directory listings under ANDA 090685
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

Showing 20 of 40.

smoothlax (Polyethylene glycol 3350) NDC 0363-1323