NDC product

Acetaminophen and Codeine Phosphate

NDC 64850-642 · Elite Laboratories, Inc.

Key facts

Product NDC 64850-642
Proprietary name Acetaminophen and Codeine Phosphate
Nonproprietary name Acetaminophen and Codeine Phosphate
Substances ACETAMINOPHEN, CODEINE PHOSPHATE
Dosage form TABLET
Route ORAL
Labeler Elite Laboratories, Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA212418
DEA schedule CIII
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
Marketing start Sep 10, 2019
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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