NDC product

POLYMYXIN B

NDC 68083-174 · Gland Pharma Limited

Key facts

Product NDC 68083-174
Proprietary name POLYMYXIN B
Nonproprietary name POLYMYXIN B SULFATE
Substances POLYMYXIN B SULFATE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS, OPHTHALMIC
Labeler Gland Pharma Limited
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA207322
Pharmacologic classes Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
Marketing start Jun 1, 2016
Listing certified through Dec 31, 2026

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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