NDC product

Hydromorphone Hydrochloride

NDC 0054-0386 · Hikma Pharmaceuticals USA Inc.

Key facts

Product NDC 0054-0386
Proprietary name Hydromorphone Hydrochloride
Nonproprietary name hydromorphone hydrochloride
Substances HYDROMORPHONE HYDROCHLORIDE
Dosage form SOLUTION
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA074653
DEA schedule CII
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
Marketing start Mar 1, 2012
Listing certified through Dec 31, 2027

At a glance

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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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