FDA.reportPublic FDA data

Ziprasidone Hydrochloride

Product NDC
63629-8150
11-digit product format
636298150
Labeler code
63629
Product ID
63629-8150_ea2b746e-ebf2-4ae2-9921-06b28cb310ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204375
Marketing category
ANDA
Marketing start
2017-02-18
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ziprasidone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZIPRASIDONE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii216X081ORU
Rxcui314286

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
defe29d6-6a09-c3aa-4400-b1130380ccc3Product name520231206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-8150-12024-05-13C16284748780-11030e365-0246-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ZIPRASIDONE CAPSULES safely and effectively. See full prescribing information for ZIPRASIDONE CAPSULES. ZIPRASIDONE capsules, for oral use Initial U.S. Approval: 2001
63629-8150-22024-05-13C16284748780-11030e365-0246-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ZIPRASIDONE CAPSULES safely and effectively. See full prescribing information for ZIPRASIDONE CAPSULES. ZIPRASIDONE capsules, for oral use Initial U.S. Approval: 2001
63629-8150-12024-01-30C16284748780-11030e365-0246-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ZIPRASIDONE CAPSULES safely and effectively. See full prescribing information for ZIPRASIDONE CAPSULES. ZIPRASIDONE capsules, for oral use Initial U.S. Approval: 2001
63629-8150-22024-01-30C16284748780-11030e365-0246-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ZIPRASIDONE CAPSULES safely and effectively. See full prescribing information for ZIPRASIDONE CAPSULES. ZIPRASIDONE capsules, for oral use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8150-1Ziprasidone Hydrochloride30 in 1 BOTTLECAPSULE305
63629-8150-2Ziprasidone Hydrochloride60 in 1 BOTTLECAPSULE605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8150ZIPRASIDONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 2 package rows20240514_550aca3a-5051-432e-9a3f-a2e53cbd603d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314286ziprasidone HCl 20 MG Oral CapsulePSN550aca3a-5051-432e-9a3f-a2e53cbd603d5
314286ziprasidone 20 MG Oral CapsuleSCD550aca3a-5051-432e-9a3f-a2e53cbd603d5
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSY550aca3a-5051-432e-9a3f-a2e53cbd603d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8150-16362981500130 CAPSULE in 1 BOTTLE (63629-8150-1) 30 capsule2024-04-030000-00-00NoNoCurrent
63629-8150-26362981500260 CAPSULE in 1 BOTTLE (63629-8150-2) 60 capsule2019-06-180000-00-00NoNoCurrent