NDC 43376-330

Zohydro

Hydrocodone Bitartrate

Zohydro is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Zogenix, Inc.. The primary component is Hydrocodone Bitartrate.

Product ID43376-330_5acca313-4e09-4063-83f3-49ffc4d6fe76
NDC43376-330
Product TypeHuman Prescription Drug
Proprietary NameZohydro
Generic NameHydrocodone Bitartrate
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2013-10-25
Marketing CategoryNDA / NDA
Application NumberNDA202880
Labeler NameZogenix, Inc.
Substance NameHYDROCODONE BITARTRATE
Active Ingredient Strength30 mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 43376-330-60

60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43376-330-60)
Marketing Start Date2013-10-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43376-330-60 [43376033060]

Zohydro CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA202880
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-10-25
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE30 mg/1

OpenFDA Data

SPL SET ID:6ccfbd98-7750-4955-a654-ec104fb666f9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1860501
  • 1860500
  • 1860499
  • 1860498
  • 1860497
  • 1860496
  • 1860495
  • 1860494
  • 1860493
  • 1860492
  • 1860491
  • 1860502

    • Pharmacological Class

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

    Medicade Reported Pricing

    43376033060 ZOHYDRO ER 30 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Zohydro" or generic name "Hydrocodone Bitartrate"

    NDCBrand NameGeneric Name
    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
    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

    Trademark Results [Zohydro]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZOHYDRO
    ZOHYDRO
    85340408 4538117 Live/Registered
    PERSION PHARMACEUTICALS LLC
    2011-06-07
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.