NDC product

Nintedanib esylate

NDC 33342-551 · Macleods Pharmaceuticals Limited

Key facts

Product NDC 33342-551
Proprietary name Nintedanib esylate
Nonproprietary name Nintedanib esylate
Substances NINTEDANIB ESYLATE
Dosage form CAPSULE
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA219926
Pharmacologic classes Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
Marketing start Aug 3, 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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