FDA.reportPublic FDA data

Ziprasidone Hydrochloride

Product NDC
50090-5420
11-digit product format
500905420
Labeler code
50090
Product ID
50090-5420_a6511c1c-9700-4ce2-9ca2-f10cd1c96124
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204375
Marketing category
ANDA
Marketing start
2017-02-18
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
40 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 HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii216X081ORU
Rxcui313776

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
50090-5420-02023-02-07C16284748780-1f386c649-ac08-0266-e053-dadaa90a7c1aThese 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
50090-5420-02023-01-30C16284748780-1f386c649-ac08-0266-e053-dadaa90a7c1aThese 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
50090-5420-0Ziprasidone Hydrochloride60 in 1 BOTTLECAPSULE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5420-0EA - Each50090-54203b0dd756-d69e-4092-b45a-36383b1ed6d812025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5420ZIPRASIDONE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 1 package rows20241114_c3797145-cead-4fc4-9711-8b8623bb09f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313776ziprasidone HCl 40 MG Oral CapsulePSNc3797145-cead-4fc4-9711-8b8623bb09f47
313776ziprasidone 40 MG Oral CapsuleSCDc3797145-cead-4fc4-9711-8b8623bb09f47
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSYc3797145-cead-4fc4-9711-8b8623bb09f47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5420-05009054200060 CAPSULE in 1 BOTTLE (50090-5420-0) 60 capsule2021-01-050000-00-00NoNoCurrent