NDC product

MiraLAX Orange Flavor

NDC 11523-0122 · Bayer HealthCare LLC.

Key facts

Product NDC 11523-0122
Proprietary name MiraLAX Orange Flavor
Nonproprietary name Polyethylene Glycol 3350
Substances POLYETHYLENE GLYCOL 3350
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Bayer HealthCare LLC.
Product type HUMAN OTC DRUG
Marketing category ANDA
Application number ANDA090685
Pharmacologic classes Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
Marketing start Sep 15, 2023
Listing certified through Dec 31, 2026

At a glance

  • 1–9 Package NDCs

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About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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