NDC 69189-2003

Ziprasidone

Ziprasidone Hydrochloride

Ziprasidone is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Avera Mckennan Hospital. The primary component is Ziprasidone Hydrochloride.

Product ID69189-2003_b9538029-9024-43e2-9ca8-35587b95ba10
NDC69189-2003
Product TypeHuman Prescription Drug
Proprietary NameZiprasidone
Generic NameZiprasidone Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-02-09
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA020825
Labeler NameAvera McKennan Hospital
Substance NameZIPRASIDONE HYDROCHLORIDE
Active Ingredient Strength40 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 69189-2003-1

1 CAPSULE in 1 DOSE PACK (69189-2003-1)
Marketing Start Date2016-02-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69189-2003-1 [69189200301]

Ziprasidone CAPSULE
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA020825
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-02-09
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ZIPRASIDONE HYDROCHLORIDE40 mg/1

OpenFDA Data

SPL SET ID:f998bc73-cc9e-47bf-a2c4-1129198905fa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313776
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    NDC Crossover Matching brand name "Ziprasidone" or generic name "Ziprasidone Hydrochloride"

    NDCBrand NameGeneric Name
    68382-238ZiprasidoneZiprasidone
    68382-239ZiprasidoneZiprasidone
    68382-237ZiprasidoneZiprasidone
    68382-240ZiprasidoneZiprasidone
    69189-2003ZiprasidoneZiprasidone
    70771-1182ZiprasidoneZiprasidone
    70771-1181ZiprasidoneZiprasidone
    70771-1180ZiprasidoneZiprasidone
    70771-1179ZiprasidoneZiprasidone
    59762-2004ZiprasidoneZiprasidone
    59762-2001ZiprasidoneZiprasidone
    59762-2002ZiprasidoneZiprasidone
    59762-2003ZiprasidoneZiprasidone
    72578-022ZiprasidoneZiprasidone
    72578-021ZiprasidoneZiprasidone
    72578-020ZiprasidoneZiprasidone
    72578-023ZiprasidoneZiprasidone
    0049-0052Geodonziprasidone hydrochloride
    0049-0054Geodonziprasidone hydrochloride
    0049-0056Geodonziprasidone hydrochloride
    0049-0058Geodonziprasidone hydrochloride
    0049-0352Geodonziprasidone
    0049-0356Geodonziprasidone
    0049-0358Geodonziprasidone

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.