FDA.reportPublic FDA data

Ziprasidone Hydrochloride

Product NDC
68084-103
11-digit product format
680840103
Labeler code
68084
Product ID
68084-103_3d34b9a4-f85e-f66c-e063-6394a90a0518
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA077561
Marketing category
ANDA
Marketing start
2014-12-16
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, 313777, 313778, 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
68084-103-09Ziprasidone Hydrochloride80 in 1 BOX, UNIT-DOSECAPSULE8010
68084-103-11Ziprasidone Hydrochloride1 in 1 BLISTER PACKCAPSULE110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-103-09EA - Each68084-103d84d23c4-9d24-4b8e-af79-03fdf26da6f712015-01-05
68084-103-11EA - Each68084-10360dbd3e0-cf6b-4367-b472-2f6bbbc41a9612015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZIPRASIDONE HYDROCHLORIDEACTIVE INGREDIENT216X081ORUZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
ZIPRASIDONEACTIVE MOIETY6UKA5VEJ6XZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
GELATININACTIVE INGREDIENT2G86QN327LZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
SHELLACINACTIVE INGREDIENT46N107B71OZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-103ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]9Current NDC, Legacy NDC, 2 package rows20241004_ba039e48-7bde-4fc5-bd39-8c9dfa98fada.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314286ziprasidone HCl 20 MG Oral CapsulePSNba039e48-7bde-4fc5-bd39-8c9dfa98fada10
313776ziprasidone HCl 40 MG Oral CapsulePSNba039e48-7bde-4fc5-bd39-8c9dfa98fada10
313777ziprasidone HCl 60 MG Oral CapsulePSNba039e48-7bde-4fc5-bd39-8c9dfa98fada10
313778ziprasidone HCl 80 MG Oral CapsulePSNba039e48-7bde-4fc5-bd39-8c9dfa98fada10
314286ziprasidone 20 MG Oral CapsuleSCDba039e48-7bde-4fc5-bd39-8c9dfa98fada10
313776ziprasidone 40 MG Oral CapsuleSCDba039e48-7bde-4fc5-bd39-8c9dfa98fada10
313777ziprasidone 60 MG Oral CapsuleSCDba039e48-7bde-4fc5-bd39-8c9dfa98fada10
313778ziprasidone 80 MG Oral CapsuleSCDba039e48-7bde-4fc5-bd39-8c9dfa98fada10
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSYba039e48-7bde-4fc5-bd39-8c9dfa98fada10
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSYba039e48-7bde-4fc5-bd39-8c9dfa98fada10
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSYba039e48-7bde-4fc5-bd39-8c9dfa98fada10
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSYba039e48-7bde-4fc5-bd39-8c9dfa98fada10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-103-096808401030980 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-103-09) / 1 CAPSULE in 1 BLISTER PACK (68084-103-11) 80 blister pack2014-12-160000-00-00NoNoCurrent
68084-103-11680840103111 in 1 BLISTER PACKHistorical