ziprasidone

Product NDC
55111-257
11-digit product format
551110257
Labeler code
55111
Product ID
55111-257_7eaaea2d-4068-4a22-c7f5-c4ac01d418a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone
Dosage form
CAPSULE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA077565
Marketing category
ANDA
Marketing start
2012-03-02
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
40 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZIPRASIDONE HYDROCHLORIDE40 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-257-01ziprasidone100 in 1 BOTTLECAPSULE10025
55111-257-05ziprasidone500 in 1 BOTTLECAPSULE50025
55111-257-30ziprasidone30 in 1 BOTTLECAPSULE3025
55111-257-60ziprasidone60 in 1 BOTTLECAPSULE6025
55111-257-78ziprasidone10 in 1 CARTONCAPSULE1025
55111-257-78ziprasidone10 in 1 BLISTER PACKCAPSULE1025
55111-257-81ziprasidone3 in 1 CARTONCAPSULE325
55111-257-81ziprasidone10 in 1 BLISTER PACKCAPSULE1025
55111-257-90ziprasidone90 in 1 BOTTLECAPSULE9025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-257-60EA - Each55111-25784a4e18b-801b-4424-9f5f-98469d93632812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ziprasidone hydrochlorideACTIVE INGREDIENT216X081ORUZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
ziprasidoneACTIVE MOIETY6UKA5VEJ6XZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
alcoholINACTIVE INGREDIENT3K9958V90MZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
ammoniaINACTIVE INGREDIENT5138Q19F1XZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3ZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
ferric oxide redINACTIVE INGREDIENT1K09F3G675ZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357ZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
gelatinINACTIVE INGREDIENT2G86QN327LZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
isopropyl alcoholINACTIVE INGREDIENTND2M416302ZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
magnesium stearateINACTIVE INGREDIENT70097M6I30ZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
povidone k30INACTIVE INGREDIENTU725QWY32XZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
propylene glycolINACTIVE INGREDIENT6DC9Q167V3ZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
shellacINACTIVE INGREDIENT46N107B71OZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
starch, cornINACTIVE INGREDIENTO8232NY3SJZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
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
55111-257ZIPRASIDONE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]22Current NDC, Legacy NDC, 9 package rows20241128_396cb4a6-01a1-f73f-2a37-39df9067bf98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313776ziprasidone HCl 40 MG Oral CapsulePSN48e6e141-66d3-4eab-b0bf-dfd1d44b4832100
313776ziprasidone 40 MG Oral CapsuleSCD48e6e141-66d3-4eab-b0bf-dfd1d44b4832100
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSY48e6e141-66d3-4eab-b0bf-dfd1d44b4832100
313776ziprasidone HCl 40 MG Oral CapsulePSN7e7261d7-4902-4bb5-a268-6c358890f96318
313776ziprasidone 40 MG Oral CapsuleSCD7e7261d7-4902-4bb5-a268-6c358890f96318
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSY7e7261d7-4902-4bb5-a268-6c358890f96318
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
313776ziprasidone HCl 40 MG Oral CapsulePSNf9b4b874-5f9b-2540-e053-6394a90a44fb1
313776ziprasidone 40 MG Oral CapsuleSCDf9b4b874-5f9b-2540-e053-6394a90a44fb1
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSYf9b4b874-5f9b-2540-e053-6394a90a44fb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-257-0155111025701100 CAPSULE in 1 BOTTLE (55111-257-01) 100 capsule2012-03-020000-00-00NoNoCurrent
55111-257-0555111025705500 CAPSULE in 1 BOTTLE (55111-257-05) 500 capsule2012-03-020000-00-00NoNoCurrent
55111-257-305511102573030 CAPSULE in 1 BOTTLE (55111-257-30) 30 capsule2012-03-020000-00-00NoNoCurrent
55111-257-605511102576060 CAPSULE in 1 BOTTLE (55111-257-60) 60 capsule2012-03-020000-00-00NoNoCurrent
55111-257-785511102577810 BLISTER PACK in 1 CARTON (55111-257-78) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2012-03-020000-00-00NoNoCurrent
55111-257-81551110257813 BLISTER PACK in 1 CARTON (55111-257-81) / 10 CAPSULE in 1 BLISTER PACK3 blister pack2012-03-020000-00-00NoNoCurrent
55111-257-905511102579090 CAPSULE in 1 BOTTLE (55111-257-90) 90 capsule2012-03-020000-00-00NoNoCurrent