NDC 0362-9048

Septocaine and Epinephrine

Articaine Hydrochloride And Epinephrine Bitartrate

Septocaine and Epinephrine is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Septodont Inc.. The primary component is Articaine Hydrochloride; Epinephrine Bitartrate.

Product ID0362-9048_1ebdfa61-8464-4a47-bb0b-83373b3cfe24
NDC0362-9048
Product TypeHuman Prescription Drug
Proprietary NameSeptocaine and Epinephrine
Generic NameArticaine Hydrochloride And Epinephrine Bitartrate
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2011-01-12
Marketing CategoryNDA / NDA
Application NumberNDA020971
Labeler NameSeptodont Inc.
Substance NameARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active Ingredient Strength40 mg/mL; mg/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 Through2020-12-31

Packaging

NDC 0362-9048-02

50 CARTRIDGE in 1 CARTON (0362-9048-02) > 1.7 mL in 1 CARTRIDGE
Marketing Start Date2011-01-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0362-9048-02 [00362904802]

Septocaine and Epinephrine INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020971
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-01-12

Drug Details

Active Ingredients

IngredientStrength
ARTICAINE HYDROCHLORIDE40 mg/mL

OpenFDA Data

SPL SET ID:0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce03
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861588
  • 1595035
  • 1595029
  • 1150829
  • 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 "Septocaine and Epinephrine" or generic name "Articaine Hydrochloride And Epinephrine Bitartrate"

    NDCBrand NameGeneric Name
    0362-9048Septocaine and EpinephrineArticaine Hydrochloride and Epinephrine Bitartrate
    0362-9049Septocaine and EpinephrineArticaine 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
    45146-110Orablocarticaine hydrochloride and epinephrine bitartrate
    45146-120Orablocarticaine hydrochloride and epinephrine bitartrate
    31382-830ZorcaineArticaine hydrochloride and Epinephrine Bitartrate

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