NDC 52120-200

Ultacan

Articaine Hydrochloride, Epinephrine Bitartrate

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

Product ID52120-200_85dfc4ff-e676-4dac-9dd8-63c15af9842c
NDC52120-200
Product TypeHuman Prescription Drug
Proprietary NameUltacan
Generic NameArticaine Hydrochloride, Epinephrine Bitartrate
Dosage FormInjection, Solution
Route of AdministrationSUBMUCOSAL
Marketing Start Date2017-07-11
Marketing CategoryANDA / ANDA
Application NumberANDA201751
Labeler NameHANSAmed, 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 FlagE
Listing Certified Through2018-12-31

Packaging

NDC 52120-200-10

100 CARTRIDGE in 1 BOX (52120-200-10) > 1.7 mL in 1 CARTRIDGE (52120-200-00)
Marketing Start Date2017-07-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52120-200-00 [52120020000]

Ultacan INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA201751
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-11

NDC 52120-200-05 [52120020005]

Ultacan INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA201751
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-11
Inactivation Date2020-01-31

NDC 52120-200-10 [52120020010]

Ultacan INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA201751
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-11
Inactivation Date2020-01-31

NDC 52120-200-01 [52120020001]

Ultacan INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA201751
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-11
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ARTICAINE HYDROCHLORIDE40 mg/mL

OpenFDA Data

SPL SET ID:e005e3da-142d-4eba-a0c0-35e05b234130
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1928862
  • 1928858
  • 1928864
  • 1928853
  • 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 "Ultacan" or generic name "Articaine Hydrochloride, Epinephrine Bitartrate"

    NDCBrand NameGeneric Name
    52120-200Ultacanarticaine hydrochloride, epinephrine bitartrate
    72304-015Articaine Hydrochloride and EpinephrineARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE
    52120-100Ultacan Fortearticaine hydrochloride, epinephrine bitartrate

    Trademark Results [Ultacan]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ULTACAN
    ULTACAN
    86489188 5583175 Live/Registered
    Sanofi-Aventis Deutschland GmbH
    2014-12-23
    ULTACAN
    ULTACAN
    85350169 not registered Dead/Abandoned
    Sanofi-Aventis Deutschland GmbH
    2011-06-20

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