NDC 71335-0148

ESZOPICLONE

Eszopiclone

ESZOPICLONE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Eszopiclone.

Product ID71335-0148_5196fdae-591b-40fa-8f13-1017e0cca590
NDC71335-0148
Product TypeHuman Prescription Drug
Proprietary NameESZOPICLONE
Generic NameEszopiclone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-09-25
Marketing CategoryANDA / ANDA
Application NumberANDA091113
Labeler NameBryant Ranch Prepack
Substance NameESZOPICLONE
Active Ingredient Strength2 mg/1
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71335-0148-1

30 TABLET, FILM COATED in 1 BOTTLE (71335-0148-1)
Marketing Start Date2017-01-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0148-5 [71335014805]

ESZOPICLONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091113
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-03

NDC 71335-0148-6 [71335014806]

ESZOPICLONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091113
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-03

NDC 71335-0148-1 [71335014801]

ESZOPICLONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091113
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-03

NDC 71335-0148-3 [71335014803]

ESZOPICLONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091113
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-03

NDC 71335-0148-7 [71335014807]

ESZOPICLONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091113
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-03

NDC 71335-0148-2 [71335014802]

ESZOPICLONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091113
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-03

NDC 71335-0148-4 [71335014804]

ESZOPICLONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091113
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-03

Drug Details

Active Ingredients

IngredientStrength
ESZOPICLONE2 mg/1

OpenFDA Data

SPL SET ID:ccd3b5a4-e541-4e39-947a-749c06994d4e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485440
  • 485442
  • 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.