FDA.reportPublic FDA data

ziprasidone hydrochloride

Product NDC
63629-6916
11-digit product format
636296916
Labeler code
63629
Product ID
63629-6916_3361a250-9104-2943-e063-6394a90a441f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077561
Marketing category
ANDA
Marketing start
2012-05-14
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
80 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 HYDROCHLORIDE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii216X081ORU
Rxcui313778

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
63629-6916-12024-05-16C16284748780-19d75b9d1-0f21-f424-e053-dadaa90a57ceThese 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
63629-6916-22024-05-16C16284748780-19d75b9d1-0f21-f424-e053-dadaa90a57ceThese 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
63629-6916-32024-05-16C16284748780-19d75b9d1-0f21-f424-e053-dadaa90a57ceThese 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
63629-6916-42024-05-16C16284748780-19d75b9d1-0f21-f424-e053-dadaa90a57ceThese 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
63629-6916-12024-01-30C16284748780-19d75b9d1-0f21-f424-e053-dadaa90a57ceThese 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
63629-6916-22024-01-30C16284748780-19d75b9d1-0f21-f424-e053-dadaa90a57ceThese 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
63629-6916-32024-01-30C16284748780-19d75b9d1-0f21-f424-e053-dadaa90a57ceThese 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
63629-6916-42024-01-30C16284748780-19d75b9d1-0f21-f424-e053-dadaa90a57ceThese 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
63629-6916-12020-10-16C16284748780-19d75b9d1-0f21-f424-e053-dadaa90a57ceThese 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
63629-6916-22020-10-16C16284748780-19d75b9d1-0f21-f424-e053-dadaa90a57ceThese 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
63629-6916-32020-10-16C16284748780-19d75b9d1-0f21-f424-e053-dadaa90a57ceThese 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
63629-6916-12020-01-31C16284748780-19d75b9d1-0f21-f424-e053-dadaa90a57ceThese 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
63629-6916-22020-01-31C16284748780-19d75b9d1-0f21-f424-e053-dadaa90a57ceThese 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
63629-6916-32020-01-31C16284748780-19d75b9d1-0f21-f424-e053-dadaa90a57ceThese 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
63629-6916-1ziprasidone hydrochloride60 in 1 BOTTLECAPSULE6014
63629-6916-2ziprasidone hydrochloride30 in 1 BOTTLECAPSULE3014
63629-6916-3ziprasidone hydrochloride28 in 1 BOTTLECAPSULE2814
63629-6916-4ziprasidone hydrochloride90 in 1 BOTTLECAPSULE9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-6916-2EA - Each63629-6916a3cd0a02-1b23-4fba-9ae7-139e941aa4f312023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-6916ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [BRYANT RANCH PREPACK]14Current NDC, Legacy NDC, 4 package rows20250424_947881af-08e6-47eb-87e3-24cc162c12bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313778ziprasidone HCl 80 MG Oral CapsulePSN947881af-08e6-47eb-87e3-24cc162c12bc14
313778ziprasidone 80 MG Oral CapsuleSCD947881af-08e6-47eb-87e3-24cc162c12bc14
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSY947881af-08e6-47eb-87e3-24cc162c12bc14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-6916-16362969160160 CAPSULE in 1 BOTTLE (63629-6916-1) 60 capsule2016-02-080000-00-00NoNoCurrent
63629-6916-26362969160230 CAPSULE in 1 BOTTLE (63629-6916-2) 30 capsule2017-04-110000-00-00NoNoCurrent
63629-6916-36362969160328 CAPSULE in 1 BOTTLE (63629-6916-3) 28 capsule2024-10-290000-00-00NoNoCurrent
63629-6916-46362969160490 CAPSULE in 1 BOTTLE (63629-6916-4) 90 capsule2024-10-290000-00-00NoNoCurrent