NDC product

Leflunomide

NDC 35573-448 · Burel Pharmaceuticals, LLC

Key facts

Product NDC 35573-448
Proprietary name Leflunomide
Nonproprietary name leflunomide
Substances LEFLUNOMIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Burel Pharmaceuticals, LLC
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA213497
Pharmacologic classes Antirheumatic Agent [EPC]
Marketing start Jan 3, 2022
Listing certified through Dec 31, 2027

At a glance

  • 1–9 Package NDCs

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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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