FDA.reportPublic FDA data

Ziprasidone Hydrochloride

Product NDC
68788-7215
11-digit product format
687887215
Labeler code
68788
Product ID
68788-7215_1cbb5590-aaf3-467d-85dd-8a32e043fb63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA204375
Marketing category
ANDA
Marketing start
2018-07-23
Marketing end
0000-00-00
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
80 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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
68788-7215-32022-01-28C16284748780-1d6a99b39-7ce7-a426-e053-dadaa90af4c2These 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
68788-7215-62022-01-28C16284748780-1d6a99b39-7ce7-a426-e053-dadaa90af4c2These 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
68788-7215-92022-01-28C16284748780-1d6a99b39-7ce7-a426-e053-dadaa90af4c2These 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
68788-7215-3Ziprasidone Hydrochloride30 in 1 BOTTLECAPSULE303
68788-7215-6Ziprasidone Hydrochloride60 in 1 BOTTLECAPSULE603
68788-7215-9Ziprasidone Hydrochloride90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7215-3EA - Each68788-7215b9d6a7a1-160f-47ce-8945-0dba460544a812018-09-05
68788-7215-6EA - Each68788-7215081cbc07-c12e-4913-938f-ef9a071b278512018-09-05
68788-7215-9EA - Each68788-7215050664a8-0587-49b8-9576-535584559a3112018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7215ZIPRASIDONE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]3Legacy NDC, 3 package rows20201020_8e8ae08e-87dc-4209-9363-cb0c7b0c8da3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313778ziprasidone HCl 80 MG Oral CapsulePSN8e8ae08e-87dc-4209-9363-cb0c7b0c8da33
313778ziprasidone 80 MG Oral CapsuleSCD8e8ae08e-87dc-4209-9363-cb0c7b0c8da33
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSY8e8ae08e-87dc-4209-9363-cb0c7b0c8da33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7215-36878872150330 CAPSULE in 1 BOTTLE (68788-7215-3) 30 capsule2018-07-230000-00-00NoNoCurrent
68788-7215-66878872150660 CAPSULE in 1 BOTTLE (68788-7215-6) 60 capsule2018-07-230000-00-00NoNoCurrent
68788-7215-96878872150990 CAPSULE in 1 BOTTLE (68788-7215-9) 90 capsule2018-07-230000-00-00NoNoCurrent