NDC 0115-1701

Albendazole

Albendazole

Albendazole is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Impax Generics. The primary component is Albendazole.

Product ID0115-1701_1003e605-1350-4b97-beae-5ce2488f4555
NDC0115-1701
Product TypeHuman Prescription Drug
Proprietary NameAlbendazole
Generic NameAlbendazole
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1996-06-11
Marketing CategoryNDA / NDA
Application NumberNDA020666
Labeler NameImpax Generics
Substance NameALBENDAZOLE
Active Ingredient Strength200 mg/1
Pharm ClassesAntihelminthic [EPC],Cytochrome P450 1A Inducers [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0115-1701-49

2 TABLET, FILM COATED in 1 BOTTLE (0115-1701-49)
Marketing Start Date1996-06-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0115-1701-49 [00115170149]

Albendazole TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020666
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1996-06-11

Drug Details

Active Ingredients

IngredientStrength
ALBENDAZOLE200 mg/1

OpenFDA Data

SPL SET ID:06b5eefc-0b95-4862-b9b6-770063f2adf0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199672
  • UPC Code
  • 0301151701496
  • Pharmacological Class

    • Antihelminthic [EPC]
    • Cytochrome P450 1A Inducers [MoA]

    NDC Crossover Matching brand name "Albendazole" or generic name "Albendazole"

    NDCBrand NameGeneric Name
    0115-1701Albendazolealbendazole
    0591-2712AlbendazoleAlbendazole
    16714-907AlbendazoleAlbendazole
    31722-935AlbendazoleAlbendazole
    42291-093AlbendazoleAlbendazole
    42799-110AlbendazoleAlbendazole
    43598-452AlbendazoleAlbendazole
    51407-258AlbendazoleAlbendazole
    54505-055AlbendazoleAlbendazole
    62980-513AlbendazoleAlbendazole
    63629-1221AlbendazoleAlbendazole
    63629-9278AlbendazoleAlbendazole
    69097-237ALBENDAZOLEalbendazole
    69539-151AlbendazoleAlbendazole
    70710-1021AlbendazoleAlbendazole
    70771-1103AlbendazoleAlbendazole
    78482-110AlbendazoleAlbendazole
    52054-550ALBENZAalbendazole
    55695-021ALBENZAalbendazole
    64896-693ALBENZAalbendazole
    65084-462ALBENZAalbendazole

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