NDC product

LOTEPREDNOL ETABONATE

NDC 0574-4135 · Padagis US LLC

Key facts

Product NDC 0574-4135
Proprietary name LOTEPREDNOL ETABONATE
Nonproprietary name loteprednol etabonate
Substances LOTEPREDNOL ETABONATE
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Padagis US LLC
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA215204
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
Marketing start Jan 12, 2026
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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