NDC 65224-315

ZOHYDRO ER

Hydrocodone Bitartrate

ZOHYDRO ER is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Persion Pharmaceuticals Llc. The primary component is Hydrocodone Bitartrate.

Product ID65224-315_20d675b2-d568-4df4-8502-ccb156b9170e
NDC65224-315
Product TypeHuman Prescription Drug
Proprietary NameZOHYDRO ER
Generic NameHydrocodone Bitartrate
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2013-10-25
Marketing CategoryNDA / NDA
Application NumberNDA202880
Labeler NamePersion Pharmaceuticals LLC
Substance NameHYDROCODONE BITARTRATE
Active Ingredient Strength15 mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 65224-315-60

60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65224-315-60)
Marketing Start Date2013-10-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65224-315-60 [65224031560]

ZOHYDRO ER CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA202880
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-10-25

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE15 mg/1

OpenFDA Data

SPL SET ID:1b89a045-d552-40b6-a717-09858b5e6239
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1860501
  • 1860500
  • 1860499
  • 1860498
  • 1860497
  • 1860496
  • 1860495
  • 1860494
  • 1860493
  • 1860492
  • 1860491
  • 1860502
    • UPC Code
  • 0365224320601

    • Pharmacological Class

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

    Medicade Reported Pricing

    65224031560 ZOHYDRO ER 15 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "ZOHYDRO ER" or generic name "Hydrocodone Bitartrate"

    NDCBrand NameGeneric Name
    65224-315ZOHYDRO ERZOHYDRO ER
    65224-330ZOHYDRO ERZOHYDRO ER
    65224-310ZOHYDRO ERZOHYDRO ER
    65224-340ZOHYDRO ERZOHYDRO ER
    65224-320ZOHYDRO ERZOHYDRO ER
    65224-350ZOHYDRO ERZOHYDRO ER
    47781-392Hydrocodone BitartrateHydrocodone Bitartrate
    47781-393Hydrocodone BitartrateHydrocodone Bitartrate
    47781-394Hydrocodone BitartrateHydrocodone Bitartrate
    47781-395Hydrocodone BitartrateHydrocodone Bitartrate
    47781-396Hydrocodone BitartrateHydrocodone Bitartrate
    47781-397Hydrocodone BitartrateHydrocodone Bitartrate
    47781-398Hydrocodone BitartrateHydrocodone Bitartrate
    47781-409Hydrocodone BitartrateHydrocodone Bitartrate
    47781-410Hydrocodone BitartrateHydrocodone Bitartrate
    47781-411Hydrocodone BitartrateHydrocodone Bitartrate
    47781-412Hydrocodone BitartrateHydrocodone Bitartrate
    47781-413Hydrocodone BitartrateHydrocodone Bitartrate
    47781-414Hydrocodone BitartrateHydrocodone Bitartrate
    43376-210Zohydrohydrocodone bitartrate
    43376-215Zohydrohydrocodone bitartrate
    43376-220Zohydrohydrocodone bitartrate
    43376-230Zohydrohydrocodone bitartrate
    43376-240Zohydrohydrocodone bitartrate
    43376-250Zohydrohydrocodone bitartrate
    43376-310Zohydrohydrocodone bitartrate
    43376-315Zohydrohydrocodone bitartrate
    43376-320Zohydrohydrocodone bitartrate
    43376-330Zohydrohydrocodone bitartrate
    43376-340Zohydrohydrocodone bitartrate
    43376-350Zohydrohydrocodone bitartrate

    Trademark Results [ZOHYDRO ER]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZOHYDRO ER
    ZOHYDRO ER
    85646921 4534120 Live/Registered
    PERSION PHARMACEUTICALS LLC
    2012-06-08
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.