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 Directory
Product 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 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 NDC11-digit (billing)PackageCopy
0536-1052-240053610522400536105224238 g in 1 BOTTLE (0536-1052-24)Marketed from Jan 5, 2015
0536-1052-270053610522700536105227510 g in 1 BOTTLE (0536-1052-27)Marketed from Jan 5, 2015
0536-1052-600053610526000536105260119 g in 1 BOTTLE (0536-1052-60)Marketed from Jul 25, 2024
0536-1052-840053610528400536105284850 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

N400536105224 followed by a unit qualifier and the quantity

Package 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other rugby PEG 3350 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
rugby PEG 3350polyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralBryant Ranch Prepack72162-215572162-2155-0272162-2155-04

Other NDCs under ANDA 090685

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 090685
ProductStrengthForm · routeLabelerProduct NDC
dg health clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralDolgencorp, LLC55910-306
good neighbor pharmacy clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralAmerisource Bergen46122-805
equaline clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralUnited Natural Foods, Inc. dba UNFI41163-306
Members Mark clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralSam's West Inc68196-306
berkley and jensen clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralBJWC68391-306
clear laxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralMeijer Distribution Inc41250-306
MiraLAX Orange Flavorpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralBayer HealthCare LLC.11523-0122
Good Neighbor Pharmacy ClearLaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralAmerisource Bergen46122-014
Exchange Select ClearLaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralArmy & Air Force Exchange Service55301-306
Good Sense Clear Laxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralPreferred Pharmaceuticals Inc.68788-8795
kirkland signature laxaclear original prescription strengthpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralCostco Wholesale Company63981-306
purelaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralCVS Pharmacy59779-306
gentle laxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralKroger Company30142-306
Topcare ClearLaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralTopco Associates LLC76162-119
rugby PEG 3350polyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralBryant Ranch Prepack72162-2155
signature care clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralSafeway21130-847
purelaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralCVS Pharmacy69842-458
Polyethylene Glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralBryant Ranch Prepack72162-2172
Clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralAmazon.com Services LLC72288-471
Gentlelaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralKroger Company30142-504

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