NDC product

Gilenya

NDC 0078-0965 · Novartis Pharmaceuticals Corporation

Key facts

Product NDC 0078-0965
Proprietary name Gilenya
Nonproprietary name Fingolimod hcl
Substances FINGOLIMOD HYDROCHLORIDE
Dosage form CAPSULE
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Product type HUMAN PRESCRIPTION DRUG
Marketing category NDA
Application number NDA022527
Pharmacologic classes Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]
Marketing start Sep 21, 2010
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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