NDC 67296-0016

Hydrocodone Acetaminophen

Hydrocodone, Acetaminophen

Hydrocodone Acetaminophen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Redpharm Drug Inc.. The primary component is Hydrocodone Bitartrate; Acetaminophen.

Product ID67296-0016_63fa3273-38d3-4855-aa4d-a4ff5b572fd2
NDC67296-0016
Product TypeHuman Prescription Drug
Proprietary NameHydrocodone Acetaminophen
Generic NameHydrocodone, Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-03-03
Marketing CategoryANDA / ANDA
Application NumberANDA081083
Labeler NameRedPharm Drug Inc.
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Active Ingredient Strength8 mg/1; mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCIII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 67296-0016-2

30 TABLET in 1 BOTTLE (67296-0016-2)
Marketing Start Date2011-03-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67296-0016-2 [67296001602]

Hydrocodone Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA081083
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-03
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE7.5 mg/1

OpenFDA Data

SPL SET ID:b165dffd-1550-4d8d-a8ea-fe83512c34e6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 833036
  • UPC Code
  • 0367296001624
  • Pharmacological Class

    • Opioid Agonist [EPC]
    • Opioid Agonists [MoA]

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