NDC 0378-4005

Alprazolam

Alprazolam

Alprazolam is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Alprazolam.

Product ID0378-4005_6cc12680-7388-49c9-a99d-dddc00efb57d
NDC0378-4005
Product TypeHuman Prescription Drug
Proprietary NameAlprazolam
Generic NameAlprazolam
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1994-01-28
Marketing CategoryANDA / ANDA
Application NumberANDA074215
Labeler NameMylan Pharmaceuticals Inc.
Substance NameALPRAZOLAM
Active Ingredient Strength1 mg/1
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-4005-05

500 TABLET in 1 BOTTLE, PLASTIC (0378-4005-05)
Marketing Start Date1994-01-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-4005-01 [00378400501]

Alprazolam TABLET
Marketing CategoryANDA
Application NumberANDA074215
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1994-01-28
Marketing End Date2016-04-26

NDC 0378-4005-05 [00378400505]

Alprazolam TABLET
Marketing CategoryANDA
Application NumberANDA074215
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1994-01-28

NDC 0378-4005-77 [00378400577]

Alprazolam TABLET
Marketing CategoryANDA
Application NumberANDA074215
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-01-05
Marketing End Date2016-04-26

Drug Details

Active Ingredients

IngredientStrength
ALPRAZOLAM1 mg/1

OpenFDA Data

SPL SET ID:f025900e-5d16-4614-93ad-7fe08a865458
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197321
  • 197322
  • 308048
  • 308047

    • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]

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

    NDCBrand NameGeneric Name
    0054-3068AlprazolamAlprazolam
    0228-2027AlprazolamAlprazolam
    68071-3049AlprazolamAlprazolam
    68071-1966AlprazolamAlprazolam
    68071-1888AlprazolamAlprazolam
    68071-1884AlprazolamAlprazolam
    68071-1929AlprazolamAlprazolam
    68071-4621AlprazolamAlprazolam
    68071-4447AlprazolamAlprazolam
    68071-4818AlprazolamAlprazolam
    68071-4831AlprazolamAlprazolam
    68071-4652AlprazolamAlprazolam
    68084-672AlprazolamAlprazolam
    68084-647AlprazolamAlprazolam
    68788-6865AlprazolamAlprazolam
    68788-0575AlprazolamAlprazolam
    68788-2029AlprazolamAlprazolam
    68788-6381AlprazolamAlprazolam
    68788-6358AlprazolamAlprazolam
    68788-2027AlprazolamAlprazolam
    68788-9430AlprazolamAlprazolam
    68788-9727AlprazolamAlprazolam
    68788-9997AlprazolamAlprazolam
    68788-9682AlprazolamAlprazolam
    70518-0000AlprazolamAlprazolam
    70518-0966AlprazolamAlprazolam
    71205-227AlprazolamAlprazolam
    71335-0163AlprazolamAlprazolam
    71335-0098AlprazolamAlprazolam
    71335-0247AlprazolamAlprazolam
    71335-0215AlprazolamAlprazolam
    71335-0252AlprazolamAlprazolam
    71335-0448AlprazolamAlprazolam
    71335-0673AlprazolamAlprazolam
    71335-0680AlprazolamAlprazolam
    71335-0761AlprazolamAlprazolam
    71335-0422AlprazolamAlprazolam
    71335-0850AlprazolamAlprazolam
    71335-0929AlprazolamAlprazolam
    71335-0813AlprazolamAlprazolam
    71335-0849AlprazolamAlprazolam
    71610-113AlprazolamAlprazolam
    71335-0920AlprazolamAlprazolam
    71610-112AlprazolamAlprazolam
    75921-901ALPRAZOLAMALPRAZOLAM
    0615-7794AlprazolamAlprazolam
    0615-7795AlprazolamAlprazolam
    0615-7793AlprazolamAlprazolam
    0615-7999AlprazolamAlprazolam
    0615-8000AlprazolamAlprazolam
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