ziprasidone hydrochloride

Product NDC
0781-2164
11-digit product format
007812164
Labeler code
0781
Product ID
0781-2164_7df70d10-a688-4718-9364-ac4915dec366
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA077562
Marketing category
ANDA
Marketing start
2013-02-13
Marketing end
0000-00-00
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-2164-60EA - Each0781-21643bcc8594-851d-4083-9ee4-4f8e10b5c4f912013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZIPRASIDONE HYDROCHLORIDEACTIVE INGREDIENT216X081ORUZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]8
ZIPRASIDONEACTIVE MOIETY6UKA5VEJ6XZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]8
AMMONIAINACTIVE INGREDIENT5138Q19F1XZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]8
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]8
CALCIUM SILICATEINACTIVE INGREDIENTS4255P4G5MZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]8
CARBOXYMETHYLCELLULOSEINACTIVE INGREDIENT05JZI7B19XZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]8
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]8
GELATININACTIVE INGREDIENT2G86QN327LZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]8
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]8
POVIDONESINACTIVE INGREDIENTFZ989GH94EZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]8
SHELLACINACTIVE INGREDIENT46N107B71OZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]8
ZIPRASIDONE HYDROCHLORIDEACTIVE INGREDIENT216X081ORUZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]4
ZIPRASIDONEACTIVE MOIETY6UKA5VEJ6XZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]4
AMMONIAINACTIVE INGREDIENT5138Q19F1XZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]4
CALCIUM SILICATEINACTIVE INGREDIENTS4255P4G5MZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]4
CARBOXYMETHYLCELLULOSEINACTIVE INGREDIENT05JZI7B19XZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]4
GELATININACTIVE INGREDIENT2G86QN327LZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]4
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]4
SHELLACINACTIVE INGREDIENT46N107B71OZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-2164ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]16Legacy NDC20250424_f3e54e15-945c-4e1e-b992-d01e6872d606.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314286ziprasidone HCl 20 MG Oral CapsulePSN5752ef72-c515-4ead-a359-69d4761ad7f44
313778ziprasidone HCl 80 MG Oral CapsulePSN5752ef72-c515-4ead-a359-69d4761ad7f44
314286ziprasidone 20 MG Oral CapsuleSCD5752ef72-c515-4ead-a359-69d4761ad7f44
313778ziprasidone 80 MG Oral CapsuleSCD5752ef72-c515-4ead-a359-69d4761ad7f44
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSY5752ef72-c515-4ead-a359-69d4761ad7f44
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSY5752ef72-c515-4ead-a359-69d4761ad7f44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-2164-600078121646060 CAPSULE in 1 BOTTLE (0781-2164-60) 60 capsule2013-02-130000-00-00NoNoCurrent