NDC 0591-0745

Estazolam

Estazolam

Estazolam is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Estazolam.

Product ID0591-0745_0188c0af-309a-4be7-b234-8cfa5b7364ca
NDC0591-0745
Product TypeHuman Prescription Drug
Proprietary NameEstazolam
Generic NameEstazolam
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1997-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA074818
Labeler NameActavis Pharma, Inc.
Substance NameESTAZOLAM
Active Ingredient Strength2 mg/1
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0591-0745-01

100 TABLET in 1 BOTTLE, PLASTIC (0591-0745-01)
Marketing Start Date1997-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-0745-01 [00591074501]

Estazolam TABLET
Marketing CategoryANDA
Application NumberANDA074818
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-10-01

Drug Details

Active Ingredients

IngredientStrength
ESTAZOLAM2 mg/1

OpenFDA Data

SPL SET ID:a1e3b4bf-22e9-430a-a768-4d86ae886c9e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197653
  • 197654
  • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]

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

    NDCBrand NameGeneric Name
    0591-0744EstazolamEstazolam
    0591-0745EstazolamEstazolam
    21695-220EstazolamEstazolam
    51862-069EstazolamEstazolam
    51862-070EstazolamEstazolam
    51862-073EstazolamEstazolam
    51862-074EstazolamEstazolam
    70954-480EstazolamEstazolam
    70954-481EstazolamEstazolam

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