Over-the-counter drug · ANDA

MiraLAX Orange Flavor (polyethylene glycol 3350) NDC 11523-0122

Polyethylene glycol 3350 17 g/17g · Powder, For solution · Oral · Bayer HealthCare LLC.

NDC codes

FDA NDC Directory
Product NDC (as listed)11523-0122Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11523-0122Add 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
11523-0122-111523012201238 g in 1 BOTTLE (11523-0122-1)Marketed from Sep 15, 2023
11523-0122-211523012202119 g in 1 BOTTLE (11523-0122-2)Marketed from Sep 15, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
MiraLAX Orange Flavor
Generic name (nonproprietary)
polyethylene glycol 3350
Active ingredients
Polyethylene glycol 3350 — 17 g/17g
Dosage form
Powder, For solution
Route
Oral
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 11523-0122_4526ca58-f032-31ad-e063-6394a90a7baeSPL ID 4526ca58-f032-31ad-e063-6394a90a7baeSPL set ID 0a5b2121-928f-8f49-e063-6394a90a8aafRxCUI 876193, 876195UNII G2M7P15E5PUPC 0041100600554
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

N411523012201 followed by a unit qualifier and the quantity

Package 11523-0122-01. 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.

Full label on DailyMed (opens in a new tab)

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
Dulcolaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowderOralChattem, Inc.41167-0223
clear laxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralH E B37808-306
Good Sense Clear Laxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralPreferred Pharmaceuticals Inc.68788-8795
Clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralAmazon.com Services LLC72288-033
kirkland signature laxaclear original prescription strengthpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralCostco Wholesale Company63981-306
Topcare ClearLaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralTopco Associates LLC76162-119
Laxativepolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralRite Aid Corporation11822-0306
Clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralSafeway21130-637
up and up powderlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralTarget Corporation11673-306
good neighbor pharmacy clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralAmerisource Bergen46122-805
careone clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralRetail Business Services, LLC72476-723
Good Neighbor Pharmacy ClearLaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralAmerisource Bergen46122-014
purelaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralCVS Pharmacy69842-458
foster and thrive clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralStrategic Sourcing Services LLC70677-1109
equaline clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralUnited Natural Foods, Inc. dba UNFI41163-306
clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralH E B59640-797
Good Sense Clear Laxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralProficient Rx LP71205-447
clear laxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralMeijer Distribution Inc41250-306
good sense clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralL. Perrigo Company0113-1023
clearlaxpolyethylene glycol 3350Polyethylene glycol 3350 17 g/17gPowder, For solutionOralPublix Super Markets Inc56062-306

Showing 20 of 39.

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