NDC 61919-119

ESZOPICLONE

Eszopiclone

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

Product ID61919-119_4be28e4b-6cc5-6b26-e054-00144ff8d46c
NDC61919-119
Product TypeHuman Prescription Drug
Proprietary NameESZOPICLONE
Generic NameEszopiclone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-03-29
Marketing CategoryANDA / ANDA
Application NumberANDA202929
Labeler NameDIRECT RX
Substance NameESZOPICLONE
Active Ingredient Strength1 mg/1
DEA ScheduleCIV
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 61919-119-90

90 TABLET, FILM COATED in 1 BOTTLE (61919-119-90)
Marketing Start Date2019-08-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-119-30 [61919011930]

ESZOPICLONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202929
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-29
Inactivation Date2020-01-31

NDC 61919-119-90 [61919011990]

ESZOPICLONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202929
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-09

Drug Details

Active Ingredients

IngredientStrength
ESZOPICLONE1 mg/1

OpenFDA Data

SPL SET ID:4be28e4b-6cc4-6b26-e054-00144ff8d46c
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
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