ziprasidone hydrochloride

Product NDC
63187-431
11-digit product format
631870431
Labeler code
63187
Product ID
63187-431_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
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, 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
63187-431-30ziprasidone hydrochloride30 in 1 BOTTLECAPSULE304
63187-431-60ziprasidone hydrochloride60 in 1 BOTTLECAPSULE604
63187-431-90ziprasidone hydrochloride90 in 1 BOTTLECAPSULE904

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZIPRASIDONE HYDROCHLORIDEACTIVE INGREDIENT216X081ORUZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [PROFICIENT RX LP]1
ZIPRASIDONEACTIVE MOIETY6UKA5VEJ6XZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [PROFICIENT RX LP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [PROFICIENT RX LP]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [PROFICIENT RX LP]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [PROFICIENT RX LP]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [PROFICIENT RX LP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [PROFICIENT RX LP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [PROFICIENT RX LP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [PROFICIENT RX LP]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [PROFICIENT RX LP]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [PROFICIENT RX LP]1
SHELLACINACTIVE INGREDIENT46N107B71OZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-431ZIPRASIDONE 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
63187-431-306318704313030 CAPSULE in 1 BOTTLE (63187-431-30) 30 capsule2015-02-020000-00-00NoNoCurrent
63187-431-606318704316060 CAPSULE in 1 BOTTLE (63187-431-60) 60 capsule2015-02-020000-00-00NoNoCurrent
63187-431-906318704319090 CAPSULE in 1 BOTTLE (63187-431-90) 90 capsule2015-02-020000-00-00NoNoCurrent