NDC product

Olopatadine Hydrochloride

NDC 0536-1445 · RUGBY LABORATORIES

Key facts

Product NDC 0536-1445
Proprietary name Olopatadine Hydrochloride
Nonproprietary name Olopatadine Hydrochloride Ophthalmic Solution
Substances OLOPATADINE HYDROCHLORIDE
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler RUGBY LABORATORIES
Product type HUMAN OTC DRUG
Marketing category ANDA
Application number ANDA206046
Pharmacologic classes Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]
Marketing start Apr 15, 2025
Listing certified through Dec 31, 2027

At a glance

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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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