Ziprasidone Hydrochloride

Product NDC
71335-0585
11-digit product format
713350585
Labeler code
71335
Product ID
71335-0585_9a0bbd38-a8a5-4d8a-82d2-c7b9ecfa8bab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204375
Marketing category
ANDA
Marketing start
2017-02-18
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
60 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 HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii216X081ORU
Rxcui313777

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
defe29d6-6a09-c3aa-4400-b1130380ccc3Product name520231206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0585-1Ziprasidone Hydrochloride30 in 1 BOTTLECAPSULE30103
71335-0585-2Ziprasidone Hydrochloride28 in 1 BOTTLECAPSULE28103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0585-1EA - Each71335-0585b0ba359e-1c43-4da8-a2ed-0250b4094e4b12018-03-08
71335-0585-2EA - Each71335-0585694b71cb-695b-41ef-89c5-06e6371b137712018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0585ZIPRASIDONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 2 package rows20231122_798631b6-b9d9-44de-9a1a-ae2cee86d531.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313777ziprasidone HCl 60 MG Oral CapsulePSN798631b6-b9d9-44de-9a1a-ae2cee86d531103
313777ziprasidone 60 MG Oral CapsuleSCD798631b6-b9d9-44de-9a1a-ae2cee86d531103
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSY798631b6-b9d9-44de-9a1a-ae2cee86d531103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0585-17133505850130 CAPSULE in 1 BOTTLE (71335-0585-1) 30 capsule2018-04-040000-00-00NoNoCurrent
71335-0585-27133505850228 CAPSULE in 1 BOTTLE (71335-0585-2) 28 capsule2022-06-280000-00-00NoNoCurrent