NDC 0054-0291

eszopiclone

Eszopiclone

eszopiclone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp.. The primary component is Eszopiclone.

Product ID0054-0291_accae4df-75e1-4493-a2f8-58bf28a327d1
NDC0054-0291
Product TypeHuman Prescription Drug
Proprietary Nameeszopiclone
Generic NameEszopiclone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-04-15
Marketing End Date2020-08-23
Marketing CategoryANDA / ANDA
Application NumberANDA091153
Labeler NameWest-Ward Pharmaceuticals Corp.
Substance NameESZOPICLONE
Active Ingredient Strength2 mg/1
DEA ScheduleCIV
NDC Exclude FlagN

Packaging

NDC 0054-0291-25

100 TABLET in 1 BOTTLE (0054-0291-25)
Marketing Start Date2014-04-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-0291-25 [00054029125]

eszopiclone TABLET
Marketing CategoryANDA
Application NumberANDA091153
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-04-15
Marketing End Date2020-08-23

Drug Details

Active Ingredients

IngredientStrength
ESZOPICLONE2 mg/1

OpenFDA Data

SPL SET ID:49f71eb4-15ca-42e2-b62b-7963cc8ef115
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485465
  • 485440
  • 485442
  • UPC Code
  • 0300540291259
  • 0300540292256
  • 0300540290139
  • NDC Crossover Matching brand name "eszopiclone" or generic name "Eszopiclone"

    NDCBrand NameGeneric Name
    0054-0290eszopicloneeszopiclone
    0054-0291eszopicloneeszopiclone
    0054-0292eszopicloneeszopiclone
    0093-5537EszopicloneEszopiclone
    0093-5538EszopicloneEszopiclone
    0093-5539EszopicloneEszopiclone
    0378-5270Eszopicloneeszopiclone
    0378-5271Eszopicloneeszopiclone
    0378-5272Eszopicloneeszopiclone
    33342-299EszopicloneEszopiclone
    33342-300EszopicloneEszopiclone
    33342-301EszopicloneEszopiclone
    68071-2153eszopicloneeszopiclone
    68071-3376EszopicloneEszopiclone
    68180-322EszopicloneEszopiclone
    68180-324EszopicloneEszopiclone
    68180-323EszopicloneEszopiclone
    68462-382EszopicloneEszopiclone
    68462-384EszopicloneEszopiclone
    68462-383EszopicloneEszopiclone
    68788-7029EszopicloneEszopiclone
    68788-7169EszopicloneEszopiclone
    68788-8923EszopicloneEszopiclone
    68788-9361eszopicloneeszopiclone
    68788-9238eszopicloneeszopiclone
    68788-6953EszopicloneEszopiclone
    68788-8953ESZOPICLONEESZOPICLONE
    68788-9296ESZOPICLONEESZOPICLONE
    68788-9315ESZOPICLONEESZOPICLONE
    68788-9824ESZOPICLONEESZOPICLONE
    68788-9318EszopicloneEszopiclone
    68788-9991ESZOPICLONEESZOPICLONE
    70518-0815EszopicloneEszopiclone
    70518-0816EszopicloneEszopiclone
    70518-1310ESZOPICLONEESZOPICLONE
    70518-0888EszopicloneEszopiclone
    71205-236ESZOPICLONEESZOPICLONE
    71335-0512EszopicloneEszopiclone
    71335-0089EszopicloneEszopiclone
    71335-0148ESZOPICLONEESZOPICLONE
    71335-0116EszopicloneEszopiclone
    71335-0784eszopicloneeszopiclone
    71335-0005ESZOPICLONEESZOPICLONE
    71335-0598EszopicloneEszopiclone
    42043-320ESZOPICLONEESZOPICLONE
    42043-321ESZOPICLONEESZOPICLONE
    42043-322ESZOPICLONEESZOPICLONE
    43063-795EszopicloneEszopiclone
    43353-101EszopicloneEszopiclone
    43353-185EszopicloneEszopiclone

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