NDC 51672-1335

Oralone

Triamcinolone Acetonide

Oralone is a Dental Paste in the Human Prescription Drug category. It is labeled and distributed by Taro Pharmaceuticals U.s.a., Inc.. The primary component is Triamcinolone Acetonide.

Product ID51672-1335_062b2f1d-cd7d-4aea-a8af-be1fee65ebfc
NDC51672-1335
Product TypeHuman Prescription Drug
Proprietary NameOralone
Generic NameTriamcinolone Acetonide
Dosage FormPaste
Route of AdministrationDENTAL
Marketing Start Date1986-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA070730
Labeler NameTaro Pharmaceuticals U.S.A., Inc.
Substance NameTRIAMCINOLONE ACETONIDE
Active Ingredient Strength1 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 51672-1335-5

1 TUBE in 1 CARTON (51672-1335-5) > 5 g in 1 TUBE
Marketing Start Date1986-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51672-1335-8 [51672133508]

Oralone PASTE
Marketing CategoryANDA
Application NumberANDA070730
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1986-10-01

NDC 51672-1335-5 [51672133505]

Oralone PASTE
Marketing CategoryANDA
Application NumberANDA070730
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1986-10-01

Drug Details

Active Ingredients

IngredientStrength
TRIAMCINOLONE ACETONIDE1 mg/g

OpenFDA Data

SPL SET ID:ac1e2116-795e-4c20-974d-11fa07cf0fa7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1085728
  • 1085767

    • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]
    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    Medicade Reported Pricing

    51672133505 ORALONE 0.1% PASTE

    Pricing Unit: GM | Drug Type:

    NDC Crossover Matching brand name "Oralone" or generic name "Triamcinolone Acetonide"

    NDCBrand NameGeneric Name
    51672-1335OraloneOralone
    0363-0811Allergy NasalTriamcinolone acetonide
    0113-7005basic care nasal allergyTriamcinolone acetonide
    0113-0443Good Sense Nasal AllergyTriamcinolone acetonide
    0003-0494KENALOG-10TRIAMCINOLONE ACETONIDE
    0003-0293KENALOG-40TRIAMCINOLONE ACETONIDE
    0003-0315KENALOG-80TRIAMCINOLONE ACETONIDE
    0168-0002triamcinolone acetonidetriamcinolone acetonide
    0168-0003triamcinolone acetonidetriamcinolone acetonide
    0168-0004triamcinolone acetonidetriamcinolone acetonide
    0168-0005Triamcinolone Acetonidetriamcinolone acetonide
    0168-0006Triamcinolone Acetonidetriamcinolone acetonide
    0168-0336triamcinolone acetonidetriamcinolone acetonide
    0168-0337triamcinolone acetonidetriamcinolone acetonide
    0440-0251Triamcinolone acetonideTriamcinolone acetonide
    0440-0317Triamcinolone acetonideTriamcinolone acetonide
    0440-0318Triamcinolone acetonideTriamcinolone acetonide
    0603-7862Triamcinolone Acetonidetriamcinolone acetonide
    0603-7864Triamcinolone AcetonideTriamcinolone Acetonide
    0316-0165TRIDERMTriamcinolone Acetonide
    0316-0170TRIDERMTriamcinolone Acetonide
    0316-0175TRIDERMTriamcinolone Acetonide
    0065-0543TRIESENCEtriamcinolone acetonide

    Trademark Results [Oralone]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ORALONE
    ORALONE
    98381858 not registered Live/Pending
    Taro Pharmaceutical Industries Ltd.
    2024-01-30
    ORALONE
    ORALONE
    88733588 not registered Live/Pending
    TARO PHARMACEUTICAL INDUSTRIES, LTD.
    2019-12-19
    ORALONE
    ORALONE
    78769700 3415861 Dead/Cancelled
    Taro Pharmaceuticals U.S.A., Inc.
    2005-12-08
    ORALONE
    ORALONE
    73789003 1570611 Live/Registered
    THAMES PHARMACAL CO., INC.
    1989-03-27
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