FDA.reportPublic FDA data

ziprasidone hydrochloride

Product NDC
71335-2236
11-digit product format
713352236
Labeler code
71335
Product ID
71335-2236_d61f0a69-f8b3-4cc3-8c88-dc6b1deeed6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077565
Marketing category
ANDA
Marketing start
2012-03-02
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
40 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 HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii216X081ORU
Rxcui313776

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
defe29d6-6a09-c3aa-4400-b1130380ccc3Product name520231206
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2236-1ziprasidone hydrochloride60 in 1 BOTTLECAPSULE60100
71335-2236-2ziprasidone hydrochloride28 in 1 BOTTLECAPSULE28100
71335-2236-3ziprasidone hydrochloride30 in 1 BOTTLECAPSULE30100
71335-2236-4ziprasidone hydrochloride90 in 1 BOTTLECAPSULE90100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2236ZIPRASIDONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 4 package rows20230908_48e6e141-66d3-4eab-b0bf-dfd1d44b4832.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313776ziprasidone HCl 40 MG Oral CapsulePSN48e6e141-66d3-4eab-b0bf-dfd1d44b4832100
313776ziprasidone 40 MG Oral CapsuleSCD48e6e141-66d3-4eab-b0bf-dfd1d44b4832100
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSY48e6e141-66d3-4eab-b0bf-dfd1d44b4832100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2236-17133522360160 CAPSULE in 1 BOTTLE (71335-2236-1) 60 capsule2023-09-07NoNoCurrent
71335-2236-27133522360228 CAPSULE in 1 BOTTLE (71335-2236-2) 28 capsule2023-09-07NoNoCurrent
71335-2236-37133522360330 CAPSULE in 1 BOTTLE (71335-2236-3) 30 capsule2023-09-07NoNoCurrent
71335-2236-47133522360490 CAPSULE in 1 BOTTLE (71335-2236-4) 90 capsule2023-09-07NoNoCurrent