NDC 0299-3820

METROGEL

Metronidazole

METROGEL is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Galderma Laboratories, L.p.. The primary component is Metronidazole.

Product ID0299-3820_23a9f282-a677-4fe8-8bda-9ec566d2918a
NDC0299-3820
Product TypeHuman Prescription Drug
Proprietary NameMETROGEL
Generic NameMetronidazole
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2005-06-30
Marketing CategoryNDA / NDA
Application NumberNDA021789
Labeler NameGalderma Laboratories, L.P.
Substance NameMETRONIDAZOLE
Active Ingredient Strength10 mg/g
Pharm ClassesNitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0299-3820-00

3 g in 1 BLISTER PACK (0299-3820-00)
Marketing Start Date2005-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0299-3820-00 [00299382000]

METROGEL GEL
Marketing CategoryNDA
Application NumberNDA021789
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-06-30

NDC 0299-3820-01 [00299382001]

METROGEL GEL
Marketing CategoryNDA
Application NumberNDA021789
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2011-10-19

NDC 0299-3820-03 [00299382003]

METROGEL GEL
Marketing CategoryNDA
Application NumberNDA021789
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-06-30

NDC 0299-3820-60 [00299382060]

METROGEL GEL
Marketing CategoryNDA
Application NumberNDA021789
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2006-08-29

NDC 0299-3820-99 [00299382099]

METROGEL GEL
Marketing CategoryNDA
Application NumberNDA021789
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-10-19

Drug Details

Active Ingredients

IngredientStrength
METRONIDAZOLE10 mg/g

OpenFDA Data

SPL SET ID:ab3a8a2d-714a-4beb-af8a-99bc3ac3ebbe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 577237
  • 605730
  • UPC Code
  • 0302993820017
  • Pharmacological Class

    • Nitroimidazole Antimicrobial [EPC]
    • Nitroimidazoles [CS]

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

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

    Trademark Results [METROGEL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    METROGEL
    METROGEL
    73702504 1499203 Live/Registered
    CURATEX PHARMACEUTICALS, INC.
    1987-12-23

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.