FDA.reportPublic FDA data

ziprasidone hydrochloride

Product NDC
63187-448
11-digit product format
631870448
Labeler code
63187
Product ID
63187-448_a5b55c92-dad3-4edd-a80b-becf1c4acc9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077561
Marketing category
ANDA
Marketing start
2012-05-14
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
20 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 HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii216X081ORU
Rxcui313776, 314286

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
63187-448-30ziprasidone hydrochloride30 in 1 BOTTLECAPSULE304
63187-448-60ziprasidone hydrochloride60 in 1 BOTTLECAPSULE604
63187-448-90ziprasidone hydrochloride90 in 1 BOTTLECAPSULE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-448ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20210115_f60b6892-a437-450d-906a-978272148feb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314286ziprasidone HCl 20 MG Oral CapsulePSNf60b6892-a437-450d-906a-978272148feb4
313776ziprasidone HCl 40 MG Oral CapsulePSNf60b6892-a437-450d-906a-978272148feb4
314286ziprasidone 20 MG Oral CapsuleSCDf60b6892-a437-450d-906a-978272148feb4
313776ziprasidone 40 MG Oral CapsuleSCDf60b6892-a437-450d-906a-978272148feb4
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSYf60b6892-a437-450d-906a-978272148feb4
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSYf60b6892-a437-450d-906a-978272148feb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-448-306318704483030 CAPSULE in 1 BOTTLE (63187-448-30) 30 capsule2015-02-020000-00-00NoNoCurrent
63187-448-606318704486060 CAPSULE in 1 BOTTLE (63187-448-60) 60 capsule2015-02-020000-00-00NoNoCurrent
63187-448-906318704489090 CAPSULE in 1 BOTTLE (63187-448-90) 90 capsule2015-02-020000-00-00NoNoCurrent