NDC 0245-0860

Vandazole

Metronidazole

Vandazole is a Vaginal Gel in the Human Prescription Drug category. It is labeled and distributed by Upsher-smith Laboratories, Llc. The primary component is Metronidazole.

Product ID0245-0860_0a2590ba-d460-4427-89bc-2c2da46b0b38
NDC0245-0860
Product TypeHuman Prescription Drug
Proprietary NameVandazole
Generic NameMetronidazole
Dosage FormGel
Route of AdministrationVAGINAL
Marketing Start Date2005-10-04
Marketing CategoryNDA / NDA
Application NumberNDA021806
Labeler NameUpsher-Smith Laboratories, LLC
Substance NameMETRONIDAZOLE
Active Ingredient Strength8 mg/g
Pharm ClassesNitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0245-0860-70

1 TUBE, WITH APPLICATOR in 1 CARTON (0245-0860-70) > 70 g in 1 TUBE, WITH APPLICATOR
Marketing Start Date2005-10-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0245-0860-70 [00245086070]

Vandazole GEL
Marketing CategoryNDA
Application NumberNDA021806
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2005-10-04

Drug Details

Active Ingredients

IngredientStrength
METRONIDAZOLE7.5 mg/g

OpenFDA Data

SPL SET ID:27d71471-8f89-4a1e-8c55-020a58961454
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 142046
  • 608934

    • Pharmacological Class

    • Nitroimidazole Antimicrobial [EPC]
    • Nitroimidazoles [CS]

    NDC Crossover Matching brand name "Vandazole" or generic name "Metronidazole"

    NDCBrand NameGeneric Name
    0245-0860VandazoleMetronidazole
    70518-2400VandazoleVandazole
    53002-7341VandazoleVandazole
    0025-1821FlagylMetronidazole
    0025-1831FlagylMetronidazole
    0025-1942Flagylmetronidazole
    0299-3836MetroCreammetronidazole
    0299-3820METROGELmetronidazole
    0299-3838MetroLotionmetronidazole
    0115-1474MetronidazoleMetronidazole
    0143-9772MetronidazoleMetronidazole
    0168-0275MetronidazoleMetronidazole
    0168-0323MetronidazoleMetronidazole
    0168-0383MetronidazoleMetronidazole
    0179-1482MetronidazoleMetronidazole
    0264-5535METRONIDAZOLEMETRONIDAZOLE
    0338-1055MetronidazoleMetronidazole
    0187-5202Noritatemetronidazole

    Trademark Results [Vandazole]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VANDAZOLE
    VANDAZOLE
    78596193 3178335 Live/Registered
    UPSHER-SMITH LABORATORIES, LLC
    2005-03-28
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