NDC product

Hydrocodone Bitartrate and Acetaminophen

NDC 0121-2316 · PAI Holdings, LLC dba PAI Pharma

Key facts

Product NDC 0121-2316
Proprietary name Hydrocodone Bitartrate and Acetaminophen
Nonproprietary name HYDROCODONE BITARTRATE and ACETAMINOPHEN
Substances HYDROCODONE BITARTRATE, ACETAMINOPHEN
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA040838
DEA schedule CII
Pharmacologic classes Opioid Agonist [EPC], Opioid Agonists [MoA]
Marketing start Jul 29, 2013
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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