NDC 68047-720

Acetaminophen, Caffeine and Dihydrocodeine Bitartrate

Acetaminophen, Caffeine And Dihydrocodeine Bitartrate

Acetaminophen, Caffeine and Dihydrocodeine Bitartrate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Larken Laboratories Inc.. The primary component is Acetaminophen; Caffeine; Dihydrocodeine Bitartrate.

Product ID68047-720_9018628a-7f4f-1fbd-e053-2995a90a41f5
Product TypeHuman Prescription Drug
Proprietary NameAcetaminophen, Caffeine and Dihydrocodeine Bitartrate
Generic NameAcetaminophen, Caffeine And Dihydrocodeine Bitartrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-10-04
Marketing CategoryANDA / ANDA
Application NumberANDA204209
Labeler NameLarken Laboratories Inc.
Active Ingredient Strength325 mg/1; mg/1; mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2020-12-31


NDC 68047-720-01

100 TABLET in 1 BOTTLE (68047-720-01)
Marketing Start Date2016-10-04
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients


OpenFDA Data

SPL SET ID:28bb5975-32f6-414a-84ed-c376da575e3f
Manufacturer:Larken Laboratories Inc.
RxNorm Concept Unique ID - RxCUI
  • 1812164
  • Pharmacological Class

    • Central Nervous System Stimulant [EPC]
    • Methylxanthine [EPC]
    • Xanthines [CS]
    • Central Nervous System Stimulation [PE]
    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]

    NDC Crossover Matching brand name "Acetaminophen, Caffeine and Dihydrocodeine Bitartrate" or generic name "Acetaminophen, Caffeine And Dihydrocodeine Bitartrate"

    NDCBrand NameGeneric Name
    68047-720Acetaminophen, Caffeine and Dihydrocodeine BitartrateAcetaminophen, Caffeine and Dihydrocodeine Bitartrate
    71993-300Acetaminophen, Caffeine and Dihydrocodeine BitartrateAcetaminophen, Caffeine and Dihydrocodeine Bitartrate
    70362-730DVORAHacetaminophen, caffeine and dihydrocodeine bitartrate
    70569-152DVORAHacetaminophen, caffeine and dihydrocodeine bitartrate

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