NDC 52959-965

ALPRAZOLAM EXTENDED-RELEASE

Alprazolam

ALPRAZOLAM EXTENDED-RELEASE is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Alprazolam.

Product ID52959-965_75fcb860-7243-49d6-8ae2-7cd989588e52
NDC52959-965
Product TypeHuman Prescription Drug
Proprietary NameALPRAZOLAM EXTENDED-RELEASE
Generic NameAlprazolam
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2007-03-28
Marketing CategoryANDA / ANDA
Application NumberANDA077996
Labeler NameH.J. Harkins Company, Inc.
Substance NameALPRAZOLAM
Active Ingredient Strength1 mg/1
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 52959-965-15

15 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52959-965-15)
Marketing Start Date2007-03-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-965-30 [52959096530]

ALPRAZOLAM EXTENDED-RELEASE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077996
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-03-28
Inactivation Date2020-01-31

NDC 52959-965-60 [52959096560]

ALPRAZOLAM EXTENDED-RELEASE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077996
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-03-28
Inactivation Date2020-01-31

NDC 52959-965-15 [52959096515]

ALPRAZOLAM EXTENDED-RELEASE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077996
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-03-28
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ALPRAZOLAM1 mg/1

OpenFDA Data

SPL SET ID:4f6c075f-e2b7-41fa-82c7-eba85cbe27a3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 433800

    • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]

    NDC Crossover Matching brand name "ALPRAZOLAM EXTENDED-RELEASE" or generic name "Alprazolam"

    NDCBrand NameGeneric Name
    52959-965ALPRAZOLAM EXTENDED-RELEASEALPRAZOLAM EXTENDED-RELEASE
    63629-1541ALPRAZOLAM EXTENDED-RELEASEALPRAZOLAM EXTENDED-RELEASE
    0054-3068AlprazolamAlprazolam
    0228-2027AlprazolamAlprazolam
    0009-0029Xanaxalprazolam
    0009-0055Xanaxalprazolam
    0009-0057Xanaxalprazolam
    0009-0059Xanaxalprazolam
    0009-0066Xanaxalprazolam
    0009-0068Xanaxalprazolam
    0009-0090Xanaxalprazolam
    0009-0094Xanaxalprazolam
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.