FDA.reportPublic FDA data

Ziprasidone Hydrochloride

Product NDC
68180-331
11-digit product format
681800331
Labeler code
68180
Product ID
68180-331_786d9ba6-7993-4e01-814c-f992f0d44e75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA077560
Marketing category
ANDA
Marketing start
2012-03-02
Marketing end
0000-00-00
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-331-07EA - Each68180-331f5a0f207-2624-4be3-9975-13e4d72a092b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZIPRASIDONE HYDROCHLORIDEACTIVE INGREDIENT216X081ORUZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
ZIPRASIDONEACTIVE MOIETY6UKA5VEJ6XZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
SHELLACINACTIVE INGREDIENT46N107B71OZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314286ziprasidone HCl 20 MG Oral CapsulePSN6f63fe2d-fe55-473f-99cd-9c8eb97e562b1
313776ziprasidone HCl 40 MG Oral CapsulePSN6f63fe2d-fe55-473f-99cd-9c8eb97e562b1
313777ziprasidone HCl 60 MG Oral CapsulePSN6f63fe2d-fe55-473f-99cd-9c8eb97e562b1
313778ziprasidone HCl 80 MG Oral CapsulePSN6f63fe2d-fe55-473f-99cd-9c8eb97e562b1
314286ziprasidone 20 MG Oral CapsuleSCD6f63fe2d-fe55-473f-99cd-9c8eb97e562b1
313776ziprasidone 40 MG Oral CapsuleSCD6f63fe2d-fe55-473f-99cd-9c8eb97e562b1
313777ziprasidone 60 MG Oral CapsuleSCD6f63fe2d-fe55-473f-99cd-9c8eb97e562b1
313778ziprasidone 80 MG Oral CapsuleSCD6f63fe2d-fe55-473f-99cd-9c8eb97e562b1
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSY6f63fe2d-fe55-473f-99cd-9c8eb97e562b1
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSY6f63fe2d-fe55-473f-99cd-9c8eb97e562b1
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSY6f63fe2d-fe55-473f-99cd-9c8eb97e562b1
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSY6f63fe2d-fe55-473f-99cd-9c8eb97e562b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-331-076818003310760 CAPSULE in 1 BOTTLE (68180-331-07) 60 capsule2012-03-020000-00-00NoNoCurrent