NDC 45146-110

Orabloc

Articaine Hydrochloride And Epinephrine Bitartrate

Orabloc is a Submucosal Injection in the Human Prescription Drug category. It is labeled and distributed by Pierrel S.p.a.. The primary component is Articaine Hydrochloride; Epinephrine Bitartrate.

Product ID45146-110_1bdd7057-5c6b-4342-80d7-55f716a2d61d
NDC45146-110
Product TypeHuman Prescription Drug
Proprietary NameOrabloc
Generic NameArticaine Hydrochloride And Epinephrine Bitartrate
Dosage FormInjection
Route of AdministrationSUBMUCOSAL
Marketing Start Date2011-03-01
Marketing CategoryNDA / NDA
Application NumberNDA022466
Labeler NamePierrel S.p.A.
Substance NameARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active Ingredient Strength40 mg/mL; ug/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 45146-110-01

100 CARTRIDGE in 1 BOX (45146-110-01) > 1.8 mL in 1 CARTRIDGE
Marketing Start Date2011-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45146-110-02 [45146011002]

Orabloc INJECTION
Marketing CategoryNDA
Application NumberNDA022466
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-03-01

NDC 45146-110-01 [45146011001]

Orabloc INJECTION
Marketing CategoryNDA
Application NumberNDA022466
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-01

Drug Details

Active Ingredients

IngredientStrength
ARTICAINE HYDROCHLORIDE40 mg/mL

OpenFDA Data

SPL SET ID:d18424f0-a691-11dd-ad8b-0800200c9a66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1091068
  • 1658966
  • 1661483
  • 1091072
  • Pharmacological Class

    • Amide Local Anesthetic [EPC]
    • Amides [CS]
    • Local Anesthesia [PE]
    • Adrenergic alpha-Agonists [MoA]
    • Adrenergic beta-Agonists [MoA]
    • alpha-Adrenergic Agonist [EPC]
    • beta-Adrenergic Agonist [EPC]
    • Catecholamine [EPC]
    • Catecholamines [CS]

    NDC Crossover Matching brand name "Orabloc" or generic name "Articaine Hydrochloride And Epinephrine Bitartrate"

    NDCBrand NameGeneric Name
    45146-110Orablocarticaine hydrochloride and epinephrine bitartrate
    45146-120Orablocarticaine hydrochloride and epinephrine bitartrate
    66312-601ArticadentArticaine hydrochloride and Epinephrine Bitartrate
    66312-602ArticadentArticaine hydrochloride and Epinephrine Bitartrate
    67239-0209Articaine HCl and Epinephrinearticaine hydrochloride and epinephrine bitartrate
    67239-0210Articaine HCl and Epinephrinearticaine hydrochloride and epinephrine bitartrate
    0362-9048Septocaine and EpinephrineArticaine Hydrochloride and Epinephrine Bitartrate
    0362-9049Septocaine and EpinephrineArticaine Hydrochloride and Epinephrine Bitartrate
    31382-830ZorcaineArticaine hydrochloride and Epinephrine Bitartrate

    Trademark Results [Orabloc]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ORABLOC
    ORABLOC
    85975640 4054202 Live/Registered
    Pierrel S.p.A.
    2010-07-21
    ORABLOC
    ORABLOC
    85089275 not registered Dead/Abandoned
    Pierrel S.p.A.
    2010-07-21
    ORABLOC
    ORABLOC
    79302585 not registered Live/Pending
    PIERREL S.P.A.
    2020-11-23

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