NDC 35356-503

Alprazolam XR

Alprazolam

Alprazolam XR is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Alprazolam.

Product ID35356-503_a5b660b5-de59-4e6f-b8dc-f740145ba84c
NDC35356-503
Product TypeHuman Prescription Drug
Proprietary NameAlprazolam XR
Generic NameAlprazolam
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2003-01-17
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021434
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameALPRAZOLAM
Active Ingredient Strength1 mg/1
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 35356-503-60

60 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-503-60)
Marketing Start Date2003-01-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-503-60 [35356050360]

Alprazolam XR TABLET, EXTENDED RELEASE
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA021434
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-01-17
Marketing End Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
ALPRAZOLAM1 mg/1

OpenFDA Data

SPL SET ID:f0bfdd42-caa1-402d-b040-1ac6082ea10a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 433800
  • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]

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

    NDCBrand NameGeneric Name
    35356-503Alprazolam XRAlprazolam XR
    35356-504Alprazolam XRAlprazolam XR
    59762-0066Alprazolam XRAlprazolam XR
    59762-0068Alprazolam XRAlprazolam XR
    59762-0059Alprazolam XRAlprazolam XR
    59762-0057Alprazolam XRAlprazolam XR
    0054-3068AlprazolamAlprazolam
    0228-2027AlprazolamAlprazolam
    0009-0029Xanaxalprazolam
    0009-0055Xanaxalprazolam
    0009-0057Xanaxalprazolam
    0009-0059Xanaxalprazolam
    0009-0066Xanaxalprazolam
    0009-0068Xanaxalprazolam
    0009-0090Xanaxalprazolam
    0009-0094Xanaxalprazolam

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