NDC product

Hydrocodone Bitartrate and Ibuprofen

NDC 13107-004 · Aurolife Pharma, LLC

Key facts

Product NDC 13107-004
Proprietary name Hydrocodone Bitartrate and Ibuprofen
Nonproprietary name Hydrocodone Bitartrate and Ibuprofen
Substances HYDROCODONE BITARTRATE, IBUPROFEN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurolife Pharma, LLC
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA204575
DEA schedule CII
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA]
Marketing start Jun 2, 2016
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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