FDA.reportPublic FDA data

Ziprasidone hydrochloride

Product NDC
55648-994
11-digit product format
556480994
Labeler code
55648
Product ID
55648-994_a1ced08e-5f3f-4d84-a39f-507734086ae2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA090348
Marketing category
ANDA
Marketing start
2012-09-01
Marketing end
0000-00-00
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
80 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
defe29d6-6a09-c3aa-4400-b1130380ccc3Product name520231206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55648-994-012020-01-31C16284748780-19d75b9d1-1b30-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ziprasidone hydrochloride safely and effectively. See full prescribing information for ziprasidone hydrochloride. Ziprasidone Hydrochloride Capsules Initial U.S. Approval: 2001
55648-994-022020-01-31C16284748780-19d75b9d1-1b30-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ziprasidone hydrochloride safely and effectively. See full prescribing information for ziprasidone hydrochloride. Ziprasidone Hydrochloride Capsules Initial U.S. Approval: 2001
55648-994-032020-01-31C16284748780-19d75b9d1-1b30-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ziprasidone hydrochloride safely and effectively. See full prescribing information for ziprasidone hydrochloride. Ziprasidone Hydrochloride Capsules Initial U.S. Approval: 2001
55648-994-042020-01-31C16284748780-19d75b9d1-1b30-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ziprasidone hydrochloride safely and effectively. See full prescribing information for ziprasidone hydrochloride. Ziprasidone Hydrochloride Capsules Initial U.S. Approval: 2001
55648-994-062020-01-31C16284748780-19d75b9d1-1b30-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ziprasidone hydrochloride safely and effectively. See full prescribing information for ziprasidone hydrochloride. Ziprasidone Hydrochloride Capsules Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-994-01Ziprasidone hydrochloride30 in 1 BOTTLECAPSULE301
55648-994-02Ziprasidone hydrochloride60 in 1 BOTTLECAPSULE601
55648-994-03Ziprasidone hydrochloride100 in 1 BOTTLECAPSULE1001
55648-994-04Ziprasidone hydrochloride500 in 1 BOTTLECAPSULE5001
55648-994-06Ziprasidone hydrochloride8 in 1 BLISTER PACKCAPSULE81
55648-994-06Ziprasidone hydrochloride10 in 1 CARTONCAPSULE101

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZIPRASIDONE HYDROCHLORIDEACTIVE INGREDIENT216X081ORUZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
ZIPRASIDONEACTIVE MOIETY6UKA5VEJ6XZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
GELATININACTIVE INGREDIENT2G86QN327LZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1UZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-994ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1Legacy NDC, 6 package rows20120906_81ca60c4-376b-43b7-b050-09e328fc403c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314286ziprasidone HCl 20 MG Oral CapsulePSN81ca60c4-376b-43b7-b050-09e328fc403c1
313776ziprasidone HCl 40 MG Oral CapsulePSN81ca60c4-376b-43b7-b050-09e328fc403c1
313777ziprasidone HCl 60 MG Oral CapsulePSN81ca60c4-376b-43b7-b050-09e328fc403c1
313778ziprasidone HCl 80 MG Oral CapsulePSN81ca60c4-376b-43b7-b050-09e328fc403c1
314286ziprasidone 20 MG Oral CapsuleSCD81ca60c4-376b-43b7-b050-09e328fc403c1
313776ziprasidone 40 MG Oral CapsuleSCD81ca60c4-376b-43b7-b050-09e328fc403c1
313777ziprasidone 60 MG Oral CapsuleSCD81ca60c4-376b-43b7-b050-09e328fc403c1
313778ziprasidone 80 MG Oral CapsuleSCD81ca60c4-376b-43b7-b050-09e328fc403c1
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSY81ca60c4-376b-43b7-b050-09e328fc403c1
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSY81ca60c4-376b-43b7-b050-09e328fc403c1
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSY81ca60c4-376b-43b7-b050-09e328fc403c1
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSY81ca60c4-376b-43b7-b050-09e328fc403c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-994-015564809940130 in 1 BOTTLEHistorical
55648-994-025564809940260 in 1 BOTTLEHistorical
55648-994-0355648099403100 in 1 BOTTLEHistorical
55648-994-0455648099404500 in 1 BOTTLEHistorical
55648-994-06556480994068 in 1 BLISTER PACKHistorical