NDC product

Codeine sulfate

NDC 0054-0245 · Hikma Pharmaceuticals USA Inc.

Key facts

Product NDC 0054-0245
Proprietary name Codeine sulfate
Nonproprietary name codeine sulfate
Substances CODEINE SULFATE
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category NDA
Application number NDA022402
DEA schedule CII
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
Marketing start Jul 16, 2009
Listing certified through Dec 31, 2026

At a glance

  • 1–9 Package NDCs

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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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