FDA.reportPublic FDA data

ziprasidone hydrochloride

Product NDC
60505-2531
11-digit product format
605052531
Labeler code
60505
Product ID
60505-2531_20299063-3ba2-3bcb-0994-317c7dc492a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA077561
Marketing category
ANDA
Marketing start
2012-05-14
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
80 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ziprasidone hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZIPRASIDONE HYDROCHLORIDE80 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
60505-2531-0ziprasidone hydrochloride8 in 1 CARTONCAPSULE823
60505-2531-0ziprasidone hydrochloride10 in 1 BLISTER PACKCAPSULE1023
60505-2531-3ziprasidone hydrochloride30 in 1 BOTTLECAPSULE3023
60505-2531-6ziprasidone hydrochloride60 in 1 BOTTLECAPSULE6023
60505-2531-8ziprasidone hydrochloride1000 in 1 BOTTLECAPSULE100023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2531-6EA - Each60505-2531f9584ff7-a29f-4802-9936-faea4a11950a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZIPRASIDONE HYDROCHLORIDEACTIVE INGREDIENT216X081ORUZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [APOTEX CORP.]7
ZIPRASIDONEACTIVE MOIETY6UKA5VEJ6XZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [APOTEX CORP.]7
ALCOHOLINACTIVE INGREDIENT3K9958V90MZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [APOTEX CORP.]7
AMMONIAINACTIVE INGREDIENT5138Q19F1XZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [APOTEX CORP.]7
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [APOTEX CORP.]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [APOTEX CORP.]7
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [APOTEX CORP.]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [APOTEX CORP.]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [APOTEX CORP.]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [APOTEX CORP.]7
GELATININACTIVE INGREDIENT2G86QN327LZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [APOTEX CORP.]7
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [APOTEX CORP.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [APOTEX CORP.]7
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [APOTEX CORP.]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [APOTEX CORP.]7
SHELLACINACTIVE INGREDIENT46N107B71OZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [APOTEX CORP.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [APOTEX CORP.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [APOTEX CORP.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [APOTEX CORP.]7
ZIPRASIDONE HYDROCHLORIDEACTIVE INGREDIENT216X081ORUZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
ZIPRASIDONE HYDROCHLORIDEACTIVE INGREDIENT216X081ORUZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
ZIPRASIDONEACTIVE MOIETY6UKA5VEJ6XZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
ZIPRASIDONEACTIVE MOIETY6UKA5VEJ6XZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]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
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]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
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
GELATININACTIVE INGREDIENT2G86QN327LZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
SHELLACINACTIVE INGREDIENT46N107B71OZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
SHELLACINACTIVE INGREDIENT46N107B71OZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]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
60505-2531ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [APOTEX CORP.]22Current NDC, Legacy NDC, 5 package rows20250411_ccfd5ba2-7271-f3dd-4c98-7418c1a4b54a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314286ziprasidone HCl 20 MG Oral CapsulePSNccfd5ba2-7271-f3dd-4c98-7418c1a4b54a23
313776ziprasidone HCl 40 MG Oral CapsulePSNccfd5ba2-7271-f3dd-4c98-7418c1a4b54a23
313777ziprasidone HCl 60 MG Oral CapsulePSNccfd5ba2-7271-f3dd-4c98-7418c1a4b54a23
313778ziprasidone HCl 80 MG Oral CapsulePSNccfd5ba2-7271-f3dd-4c98-7418c1a4b54a23
314286ziprasidone 20 MG Oral CapsuleSCDccfd5ba2-7271-f3dd-4c98-7418c1a4b54a23
313776ziprasidone 40 MG Oral CapsuleSCDccfd5ba2-7271-f3dd-4c98-7418c1a4b54a23
313777ziprasidone 60 MG Oral CapsuleSCDccfd5ba2-7271-f3dd-4c98-7418c1a4b54a23
313778ziprasidone 80 MG Oral CapsuleSCDccfd5ba2-7271-f3dd-4c98-7418c1a4b54a23
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSYccfd5ba2-7271-f3dd-4c98-7418c1a4b54a23
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSYccfd5ba2-7271-f3dd-4c98-7418c1a4b54a23
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSYccfd5ba2-7271-f3dd-4c98-7418c1a4b54a23
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSYccfd5ba2-7271-f3dd-4c98-7418c1a4b54a23
313778ziprasidone HCl 80 MG Oral CapsulePSN947881af-08e6-47eb-87e3-24cc162c12bc14
313778ziprasidone 80 MG Oral CapsuleSCD947881af-08e6-47eb-87e3-24cc162c12bc14
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSY947881af-08e6-47eb-87e3-24cc162c12bc14
314286ziprasidone HCl 20 MG Oral CapsulePSNb1f52226-4fb4-48bf-8bfd-0c9df6ca02fa12
313776ziprasidone HCl 40 MG Oral CapsulePSNb1f52226-4fb4-48bf-8bfd-0c9df6ca02fa12
313777ziprasidone HCl 60 MG Oral CapsulePSNb1f52226-4fb4-48bf-8bfd-0c9df6ca02fa12
313778ziprasidone HCl 80 MG Oral CapsulePSNb1f52226-4fb4-48bf-8bfd-0c9df6ca02fa12
314286ziprasidone 20 MG Oral CapsuleSCDb1f52226-4fb4-48bf-8bfd-0c9df6ca02fa12
313776ziprasidone 40 MG Oral CapsuleSCDb1f52226-4fb4-48bf-8bfd-0c9df6ca02fa12
313777ziprasidone 60 MG Oral CapsuleSCDb1f52226-4fb4-48bf-8bfd-0c9df6ca02fa12
313778ziprasidone 80 MG Oral CapsuleSCDb1f52226-4fb4-48bf-8bfd-0c9df6ca02fa12
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSYb1f52226-4fb4-48bf-8bfd-0c9df6ca02fa12
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSYb1f52226-4fb4-48bf-8bfd-0c9df6ca02fa12
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSYb1f52226-4fb4-48bf-8bfd-0c9df6ca02fa12
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSYb1f52226-4fb4-48bf-8bfd-0c9df6ca02fa12
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 CapsulePSNec4634d5-10c2-4e2e-8a3d-35babce28be710
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 CapsuleSCDec4634d5-10c2-4e2e-8a3d-35babce28be710
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 CapsuleSYec4634d5-10c2-4e2e-8a3d-35babce28be710
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSYba039e48-7bde-4fc5-bd39-8c9dfa98fada10
314286ziprasidone HCl 20 MG Oral CapsulePSNc227a618-1274-2b4d-e053-2a95a90a74fb4
313776ziprasidone HCl 40 MG Oral CapsulePSNc227a618-1274-2b4d-e053-2a95a90a74fb4
313777ziprasidone HCl 60 MG Oral CapsulePSNc227a618-1274-2b4d-e053-2a95a90a74fb4
313778ziprasidone HCl 80 MG Oral CapsulePSNc227a618-1274-2b4d-e053-2a95a90a74fb4
314286ziprasidone 20 MG Oral CapsuleSCDc227a618-1274-2b4d-e053-2a95a90a74fb4
313776ziprasidone 40 MG Oral CapsuleSCDc227a618-1274-2b4d-e053-2a95a90a74fb4
313777ziprasidone 60 MG Oral CapsuleSCDc227a618-1274-2b4d-e053-2a95a90a74fb4
313778ziprasidone 80 MG Oral CapsuleSCDc227a618-1274-2b4d-e053-2a95a90a74fb4
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSYc227a618-1274-2b4d-e053-2a95a90a74fb4
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSYc227a618-1274-2b4d-e053-2a95a90a74fb4
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSYc227a618-1274-2b4d-e053-2a95a90a74fb4
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSYc227a618-1274-2b4d-e053-2a95a90a74fb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-2531-0605052531008 BLISTER PACK in 1 CARTON (60505-2531-0) > 10 CAPSULE in 1 BLISTER PACK8 blister pack2012-05-140000-00-00NoNoCurrent
60505-2531-36050525310330 CAPSULE in 1 BOTTLE (60505-2531-3) 30 capsule2012-05-140000-00-00NoNoCurrent
60505-2531-66050525310660 CAPSULE in 1 BOTTLE (60505-2531-6) 60 capsule2012-05-140000-00-00NoNoCurrent
60505-2531-8605052531081000 CAPSULE in 1 BOTTLE (60505-2531-8) 1000 capsule2012-05-140000-00-00NoNoCurrent