NDC product

Lactulose

NDC 0116-4005 · Xttrium Laboratories, Inc.

Key facts

Product NDC 0116-4005
Proprietary name Lactulose
Nonproprietary name Lactulose
Substances LACTULOSE
Dosage form SOLUTION
Route ORAL
Labeler Xttrium Laboratories, Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA075911
Pharmacologic classes Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
Marketing start Jul 1, 2022
Listing certified through Dec 31, 2027

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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