FDA.reportPublic FDA data

ziprasidone hydrochloride

Product NDC
60429-767
11-digit product format
604290767
Labeler code
60429
Product ID
60429-767_32fe222b-27ec-e636-e063-6294a90aa2ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA077561
Marketing category
ANDA
Marketing start
2012-03-02
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
60 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 HYDROCHLORIDE60 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
60429-767-60ziprasidone hydrochloride60 in 1 BOTTLECAPSULE6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-767-60EA - Each60429-7672b1defa0-1f3d-4675-95d5-947f1955ef9312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZIPRASIDONE HYDROCHLORIDEACTIVE INGREDIENT216X081ORUZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
ZIPRASIDONEACTIVE MOIETY6UKA5VEJ6XZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]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
CROSPOVIDONEINACTIVE INGREDIENT68401960MKZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]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 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
GELATININACTIVE INGREDIENT2G86QN327LZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]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
SHELLACINACTIVE INGREDIENT46N107B71OZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]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
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-767ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]12Current NDC, Legacy NDC, 1 package rows20250424_b1f52226-4fb4-48bf-8bfd-0c9df6ca02fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-767-606042907676060 CAPSULE in 1 BOTTLE (60429-767-60) 60 capsule2012-07-200000-00-00NoNoCurrent