FDA.reportPublic FDA data

Ziprasidone

Product NDC
0904-6271
11-digit product format
009046271
Labeler code
0904
Product ID
0904-6271_11aa05a7-d934-4932-990a-da13164d3825
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA077565
Marketing category
ANDA
Marketing start
2012-03-15
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
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
0904-6271-08Ziprasidone40 in 1 CARTONCAPSULE4010
0904-6271-08Ziprasidone1 in 1 BLISTER PACKCAPSULE110
0904-6271-45Ziprasidone80 in 1 CARTONCAPSULE8010
0904-6271-45Ziprasidone1 in 1 BLISTER PACKCAPSULE110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6271-08EA - Each0904-62713625116b-4822-4af9-8498-472a99867f5e12012-07-24
0904-6271-45EA - Each0904-6271a242c903-9d33-44cf-8ea7-6b53333b708512019-04-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZIPRASIDONE HYDROCHLORIDEACTIVE INGREDIENT216X081ORUZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
ZIPRASIDONEACTIVE MOIETY6UKA5VEJ6XZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
1-PROPOXY-2-PROPANOLINACTIVE INGREDIENT152BY1743WZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
GELATININACTIVE INGREDIENT2G86QN327LZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
PHENOXYISOPROPANOLINACTIVE INGREDIENT87CZY0NY1AZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
SHELLACINACTIVE INGREDIENT46N107B71OZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6271ZIPRASIDONE CAPSULE [MAJOR PHARMACEUTICALS]9Current NDC, Legacy NDC, 4 package rows20241228_ca55c149-5b9a-4144-b586-37cb5e84dc4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314286ziprasidone HCl 20 MG Oral CapsulePSNca55c149-5b9a-4144-b586-37cb5e84dc4e10
313776ziprasidone HCl 40 MG Oral CapsulePSNca55c149-5b9a-4144-b586-37cb5e84dc4e10
313777ziprasidone HCl 60 MG Oral CapsulePSNca55c149-5b9a-4144-b586-37cb5e84dc4e10
313778ziprasidone HCl 80 MG Oral CapsulePSNca55c149-5b9a-4144-b586-37cb5e84dc4e10
314286ziprasidone 20 MG Oral CapsuleSCDca55c149-5b9a-4144-b586-37cb5e84dc4e10
313776ziprasidone 40 MG Oral CapsuleSCDca55c149-5b9a-4144-b586-37cb5e84dc4e10
313777ziprasidone 60 MG Oral CapsuleSCDca55c149-5b9a-4144-b586-37cb5e84dc4e10
313778ziprasidone 80 MG Oral CapsuleSCDca55c149-5b9a-4144-b586-37cb5e84dc4e10
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSYca55c149-5b9a-4144-b586-37cb5e84dc4e10
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSYca55c149-5b9a-4144-b586-37cb5e84dc4e10
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSYca55c149-5b9a-4144-b586-37cb5e84dc4e10
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSYca55c149-5b9a-4144-b586-37cb5e84dc4e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6271-080090462710840 BLISTER PACK in 1 CARTON (0904-6271-08) / 1 CAPSULE in 1 BLISTER PACK40 blister pack2012-03-150000-00-00NoNoCurrent
0904-6271-450090462714580 BLISTER PACK in 1 CARTON (0904-6271-45) / 1 CAPSULE in 1 BLISTER PACK80 blister pack2012-03-150000-00-00NoNoCurrent