NDC product

Labetalol Hydrochloride

NDC 10135-713 · Marlex Pharmaceuticals Inc

Key facts

Product NDC 10135-713
Proprietary name Labetalol Hydrochloride
Nonproprietary name Labetalol
Substances LABETALOL
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Marlex Pharmaceuticals Inc
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA075215
Pharmacologic classes Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
Marketing start Oct 1, 2020
Listing certified through Dec 31, 2026

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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