FDA.reportPublic FDA data

ziprasidone hydrochloride

Product NDC
50090-2928
11-digit product format
500902928
Labeler code
50090
Product ID
50090-2928_c0e5ea40-2aa3-4f2b-a9f0-4bc86489a7a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077561
Marketing category
ANDA
Marketing start
2012-05-14
Marketing end
0000-00-00
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
80 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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
50090-2928-02020-01-31C16284748780-19d75b9d0-c652-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZIPRASIDONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for ZIPRASIDONE HYDROCHLORIDE CAPSULES . ZIPRASIDONE HYDROCHLORIDE capsules , for oral use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2928-0ziprasidone hydrochloride40 in 1 BOX, UNIT-DOSECAPSULE4010
50090-2928-0ziprasidone hydrochloride1 in 1 BLISTER PACKCAPSULE110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2928-0EA - Each50090-2928afb12dee-e10c-4cda-aed7-d65abfa8d56112019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2928ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [A-S MEDICATION SOLUTIONS]10Legacy NDC, 2 package rows20171120_ec4634d5-10c2-4e2e-8a3d-35babce28be7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313778ziprasidone HCl 80 MG Oral CapsulePSNec4634d5-10c2-4e2e-8a3d-35babce28be710
313778ziprasidone 80 MG Oral CapsuleSCDec4634d5-10c2-4e2e-8a3d-35babce28be710
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSYec4634d5-10c2-4e2e-8a3d-35babce28be710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-2928-05009029280040 in 1 BOX, UNIT-DOSEHistorical