NDC 68788-9318

Eszopiclone

Eszopiclone

Eszopiclone is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals, Inc.. The primary component is Eszopiclone.

Product ID68788-9318_3861c2e5-9f89-4588-8b15-b21043a45a9e
NDC68788-9318
Product TypeHuman Prescription Drug
Proprietary NameEszopiclone
Generic NameEszopiclone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-04-15
Marketing CategoryANDA / ANDA
Application NumberANDA091166
Labeler NamePreferred Pharmaceuticals, Inc.
Substance NameESZOPICLONE
Active Ingredient Strength1 mg/1
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68788-9318-0

100 TABLET, FILM COATED in 1 BOTTLE (68788-9318-0)
Marketing Start Date2015-04-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-9318-9 [68788931809]

Eszopiclone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091166
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-15
Marketing End Date2020-05-15

NDC 68788-9318-3 [68788931803]

Eszopiclone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091166
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-15
Marketing End Date2020-05-15

NDC 68788-9318-7 [68788931807]

Eszopiclone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091166
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-15
Marketing End Date2020-05-15

NDC 68788-9318-5 [68788931805]

Eszopiclone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091166
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-15
Marketing End Date2020-05-15

NDC 68788-9318-0 [68788931800]

Eszopiclone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091166
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-15
Marketing End Date2020-05-15

NDC 68788-9318-6 [68788931806]

Eszopiclone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091166
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-15
Marketing End Date2020-05-15

NDC 68788-9318-1 [68788931801]

Eszopiclone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091166
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-15
Marketing End Date2020-05-15

Drug Details

Active Ingredients

IngredientStrength
ESZOPICLONE1 mg/1

OpenFDA Data

SPL SET ID:5e638ca7-6df0-404c-8e8c-97f7a71c3278
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485440

    • 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.