NDC product

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

NDC 0054-0843 · Hikma Pharmaceuticals USA Inc.

Key facts

Product NDC 0054-0843
Proprietary name HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Nonproprietary name HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Substances HYDROCODONE BITARTRATE, ACETAMINOPHEN
Dosage form LIQUID
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA040881
DEA schedule CII
Pharmacologic classes Opioid Agonist [EPC], Opioid Agonists [MoA]
Marketing start Jun 2, 2025
Listing certified through Dec 31, 2027

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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