FDA.reportPublic FDA data

Geodon

Product NDC
64725-3920
11-digit product format
647253920
Labeler code
64725
Product ID
64725-3920_00a908e6-006f-489e-bf83-f565f9f320c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone mesylate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
TYA Pharmaceuticals
Application
NDA020919
Marketing category
NDA
Marketing start
2003-12-23
Marketing end
0000-00-00
Substance
ZIPRASIDONE MESYLATE
Active strength
20 mg/mL
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
64725-3920-12020-01-31C16284748780-19d75b9cf-e1da-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GEODON safely and effectively. See full prescribing information for GEODON. GEODON (ziprasidone HCl) capsules GEODON (ziprasidone mesylate) injection for intramuscular use Initial U.S. Approval: 2001 ® ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-3920-1Geodon10 mL in 1 CARTONINJECTION, POWDER, LYOPHILIZED,102

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZIPRASIDONE MESYLATEACTIVE INGREDIENT3X6SAX83JZGEODON (ZIPRASIDONE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TYA PHARMACEUTICALS]2
ZIPRASIDONEACTIVE MOIETY6UKA5VEJ6XGEODON (ZIPRASIDONE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TYA PHARMACEUTICALS]2
METHANESULFONIC ACIDINACTIVE INGREDIENT12EH9M7279GEODON (ZIPRASIDONE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TYA PHARMACEUTICALS]2
SULFOBUTYLETHER .BETA.-CYCLODEXTRININACTIVE INGREDIENT2PP9364507GEODON (ZIPRASIDONE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-3920GEODON (ZIPRASIDONE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20141031_136aeec3-b918-4157-b2a7-dd615e36183f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
352228Geodon 20 MG InjectionPSN136aeec3-b918-4157-b2a7-dd615e36183f2
351223ziprasidone 20 MG InjectionPSN136aeec3-b918-4157-b2a7-dd615e36183f2
352228ziprasidone 20 MG Injection [Geodon]SBD136aeec3-b918-4157-b2a7-dd615e36183f2
351223ziprasidone 20 MG InjectionSCD136aeec3-b918-4157-b2a7-dd615e36183f2
352228Geodon (as ziprasidone mesylate) 20 MG InjectionSY136aeec3-b918-4157-b2a7-dd615e36183f2
352228Geodon 20 MG InjectionSY136aeec3-b918-4157-b2a7-dd615e36183f2
351223ziprasidone (as ziprasidone mesylate) 20 MG InjectionSY136aeec3-b918-4157-b2a7-dd615e36183f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
64725-3920-16472539200110 mL in 1 CARTON10 mlHistorical