FDA.reportPublic FDA data

Geodon

Product NDC
0049-3980
11-digit product format
000493980
Labeler code
0049
Product ID
0049-3980_c8fe24dc-053a-4a1b-9c12-f0d578688d5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Roerig
Application
NDA020825
Marketing category
NDA
Marketing start
2001-02-05
Marketing end
0000-00-00
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0049-3980-60Geodon60 in 1 BOTTLECAPSULE6048

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0049-3980-41EA - Each0049-3980f2e33333-5822-45ee-9625-d523a686489712012-07-24
0049-3980-60EA - Each0049-3980d0eca3c3-369e-42ac-a4c6-0e35683859da12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZIPRASIDONE HYDROCHLORIDEACTIVE INGREDIENT216X081ORUGEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE GEODON (ZIPRASIDONE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG]27
ZIPRASIDONE MESYLATEACTIVE INGREDIENT3X6SAX83JZGEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE GEODON (ZIPRASIDONE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG]27
ZIPRASIDONEACTIVE MOIETY6UKA5VEJ6XGEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE GEODON (ZIPRASIDONE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG]27
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GGEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE GEODON (ZIPRASIDONE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG]27
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE GEODON (ZIPRASIDONE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG]27
METHANESULFONIC ACIDINACTIVE INGREDIENT12EH9M7279GEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE GEODON (ZIPRASIDONE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG]27
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE GEODON (ZIPRASIDONE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG]27
SULFOBUTYLETHER .BETA.-CYCLODEXTRININACTIVE INGREDIENT2PP9364507GEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE GEODON (ZIPRASIDONE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG]27
ziprasidone hydrochlorideACTIVE INGREDIENT216X081ORUGEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
ZIPRASIDONE HYDROCHLORIDEACTIVE INGREDIENT216X081ORUGEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ziprasidoneACTIVE MOIETY6UKA5VEJ6XGEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
ziprasidoneACTIVE MOIETY6UKA5VEJ6XGEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
lactoseINACTIVE INGREDIENTJ2B2A4N98GGEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GGEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
magnesium stearateINACTIVE INGREDIENT70097M6I30GEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0049-3980GEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE GEODON (ZIPRASIDONE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GEODON (ZIPRASIDONE) CAPSULE [ROERIG]46Legacy NDC, 1 package rows20250129_8326928a-2cb6-4f7f-9712-03a425a14c37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
352228Geodon 20 MG InjectionPSN8326928a-2cb6-4f7f-9712-03a425a14c3748
285127Geodon 20 MG Oral CapsulePSN8326928a-2cb6-4f7f-9712-03a425a14c3748
284548Geodon 40 MG Oral CapsulePSN8326928a-2cb6-4f7f-9712-03a425a14c3748
284549Geodon 60 MG Oral CapsulePSN8326928a-2cb6-4f7f-9712-03a425a14c3748
284550Geodon 80 MG Oral CapsulePSN8326928a-2cb6-4f7f-9712-03a425a14c3748
351223ziprasidone 20 MG InjectionPSN8326928a-2cb6-4f7f-9712-03a425a14c3748
314286ziprasidone HCl 20 MG Oral CapsulePSN8326928a-2cb6-4f7f-9712-03a425a14c3748
313776ziprasidone HCl 40 MG Oral CapsulePSN8326928a-2cb6-4f7f-9712-03a425a14c3748
313777ziprasidone HCl 60 MG Oral CapsulePSN8326928a-2cb6-4f7f-9712-03a425a14c3748
313778ziprasidone HCl 80 MG Oral CapsulePSN8326928a-2cb6-4f7f-9712-03a425a14c3748
352228ziprasidone 20 MG Injection [Geodon]SBD8326928a-2cb6-4f7f-9712-03a425a14c3748
285127ziprasidone 20 MG Oral Capsule [Geodon]SBD8326928a-2cb6-4f7f-9712-03a425a14c3748
284548ziprasidone 40 MG Oral Capsule [Geodon]SBD8326928a-2cb6-4f7f-9712-03a425a14c3748
284549ziprasidone 60 MG Oral Capsule [Geodon]SBD8326928a-2cb6-4f7f-9712-03a425a14c3748
284550ziprasidone 80 MG Oral Capsule [Geodon]SBD8326928a-2cb6-4f7f-9712-03a425a14c3748
351223ziprasidone 20 MG InjectionSCD8326928a-2cb6-4f7f-9712-03a425a14c3748
314286ziprasidone 20 MG Oral CapsuleSCD8326928a-2cb6-4f7f-9712-03a425a14c3748
313776ziprasidone 40 MG Oral CapsuleSCD8326928a-2cb6-4f7f-9712-03a425a14c3748
313777ziprasidone 60 MG Oral CapsuleSCD8326928a-2cb6-4f7f-9712-03a425a14c3748
313778ziprasidone 80 MG Oral CapsuleSCD8326928a-2cb6-4f7f-9712-03a425a14c3748
285127Geodon (as ziprasidone hydrochloride monohydrate) 20 MG Oral CapsuleSY8326928a-2cb6-4f7f-9712-03a425a14c3748
284548Geodon (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSY8326928a-2cb6-4f7f-9712-03a425a14c3748
284549Geodon (as ziprasidone hydrochloride monohydrate) 60 MG Oral CapsuleSY8326928a-2cb6-4f7f-9712-03a425a14c3748
284550Geodon (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSY8326928a-2cb6-4f7f-9712-03a425a14c3748
352228Geodon (as ziprasidone mesylate) 20 MG InjectionSY8326928a-2cb6-4f7f-9712-03a425a14c3748
352228Geodon 20 MG InjectionSY8326928a-2cb6-4f7f-9712-03a425a14c3748
285127Geodon 20 MG Oral CapsuleSY8326928a-2cb6-4f7f-9712-03a425a14c3748
284548Geodon 40 MG Oral CapsuleSY8326928a-2cb6-4f7f-9712-03a425a14c3748
284549Geodon 60 MG Oral CapsuleSY8326928a-2cb6-4f7f-9712-03a425a14c3748
284550Geodon 80 MG Oral CapsuleSY8326928a-2cb6-4f7f-9712-03a425a14c3748
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSY8326928a-2cb6-4f7f-9712-03a425a14c3748
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSY8326928a-2cb6-4f7f-9712-03a425a14c3748
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSY8326928a-2cb6-4f7f-9712-03a425a14c3748
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSY8326928a-2cb6-4f7f-9712-03a425a14c3748
351223ziprasidone (as ziprasidone mesylate) 20 MG InjectionSY8326928a-2cb6-4f7f-9712-03a425a14c3748
285127Geodon 20 MG Oral CapsulePSNfa358b08-ca8c-4919-9217-59c11e977ed71
285127Geodon 20 MG Oral CapsulePSNa3aa96bb-2cc1-4316-b94c-61593e9275051
284548Geodon 40 MG Oral CapsulePSNa3aa96bb-2cc1-4316-b94c-61593e9275051
284548Geodon 40 MG Oral CapsulePSNfa358b08-ca8c-4919-9217-59c11e977ed71
284549Geodon 60 MG Oral CapsulePSNfa358b08-ca8c-4919-9217-59c11e977ed71
284549Geodon 60 MG Oral CapsulePSNa3aa96bb-2cc1-4316-b94c-61593e9275051
284550Geodon 80 MG Oral CapsulePSNfa358b08-ca8c-4919-9217-59c11e977ed71
284550Geodon 80 MG Oral CapsulePSNa3aa96bb-2cc1-4316-b94c-61593e9275051
314286ziprasidone HCl 20 MG Oral CapsulePSNfa358b08-ca8c-4919-9217-59c11e977ed71
314286ziprasidone HCl 20 MG Oral CapsulePSNa3aa96bb-2cc1-4316-b94c-61593e9275051
313776ziprasidone HCl 40 MG Oral CapsulePSNfa358b08-ca8c-4919-9217-59c11e977ed71
313776ziprasidone HCl 40 MG Oral CapsulePSNa3aa96bb-2cc1-4316-b94c-61593e9275051
313777ziprasidone HCl 60 MG Oral CapsulePSNa3aa96bb-2cc1-4316-b94c-61593e9275051
313777ziprasidone HCl 60 MG Oral CapsulePSNfa358b08-ca8c-4919-9217-59c11e977ed71
313778ziprasidone HCl 80 MG Oral CapsulePSNa3aa96bb-2cc1-4316-b94c-61593e9275051
313778ziprasidone HCl 80 MG Oral CapsulePSNfa358b08-ca8c-4919-9217-59c11e977ed71
285127ziprasidone 20 MG Oral Capsule [Geodon]SBDfa358b08-ca8c-4919-9217-59c11e977ed71
285127ziprasidone 20 MG Oral Capsule [Geodon]SBDa3aa96bb-2cc1-4316-b94c-61593e9275051
284548ziprasidone 40 MG Oral Capsule [Geodon]SBDfa358b08-ca8c-4919-9217-59c11e977ed71
284548ziprasidone 40 MG Oral Capsule [Geodon]SBDa3aa96bb-2cc1-4316-b94c-61593e9275051
284549ziprasidone 60 MG Oral Capsule [Geodon]SBDfa358b08-ca8c-4919-9217-59c11e977ed71
284549ziprasidone 60 MG Oral Capsule [Geodon]SBDa3aa96bb-2cc1-4316-b94c-61593e9275051
284550ziprasidone 80 MG Oral Capsule [Geodon]SBDa3aa96bb-2cc1-4316-b94c-61593e9275051
284550ziprasidone 80 MG Oral Capsule [Geodon]SBDfa358b08-ca8c-4919-9217-59c11e977ed71
314286ziprasidone 20 MG Oral CapsuleSCDfa358b08-ca8c-4919-9217-59c11e977ed71
314286ziprasidone 20 MG Oral CapsuleSCDa3aa96bb-2cc1-4316-b94c-61593e9275051
313776ziprasidone 40 MG Oral CapsuleSCDa3aa96bb-2cc1-4316-b94c-61593e9275051
313776ziprasidone 40 MG Oral CapsuleSCDfa358b08-ca8c-4919-9217-59c11e977ed71
313777ziprasidone 60 MG Oral CapsuleSCDfa358b08-ca8c-4919-9217-59c11e977ed71
313777ziprasidone 60 MG Oral CapsuleSCDa3aa96bb-2cc1-4316-b94c-61593e9275051
313778ziprasidone 80 MG Oral CapsuleSCDa3aa96bb-2cc1-4316-b94c-61593e9275051
313778ziprasidone 80 MG Oral CapsuleSCDfa358b08-ca8c-4919-9217-59c11e977ed71
285127Geodon (as ziprasidone hydrochloride monohydrate) 20 MG Oral CapsuleSYa3aa96bb-2cc1-4316-b94c-61593e9275051
285127Geodon (as ziprasidone hydrochloride monohydrate) 20 MG Oral CapsuleSYfa358b08-ca8c-4919-9217-59c11e977ed71
284548Geodon (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSYa3aa96bb-2cc1-4316-b94c-61593e9275051
284548Geodon (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSYfa358b08-ca8c-4919-9217-59c11e977ed71
284549Geodon (as ziprasidone hydrochloride monohydrate) 60 MG Oral CapsuleSYa3aa96bb-2cc1-4316-b94c-61593e9275051
284549Geodon (as ziprasidone hydrochloride monohydrate) 60 MG Oral CapsuleSYfa358b08-ca8c-4919-9217-59c11e977ed71
284550Geodon (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSYfa358b08-ca8c-4919-9217-59c11e977ed71
284550Geodon (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSYa3aa96bb-2cc1-4316-b94c-61593e9275051
285127Geodon 20 MG Oral CapsuleSYa3aa96bb-2cc1-4316-b94c-61593e9275051
285127Geodon 20 MG Oral CapsuleSYfa358b08-ca8c-4919-9217-59c11e977ed71
284548Geodon 40 MG Oral CapsuleSYfa358b08-ca8c-4919-9217-59c11e977ed71
284548Geodon 40 MG Oral CapsuleSYa3aa96bb-2cc1-4316-b94c-61593e9275051
284549Geodon 60 MG Oral CapsuleSYfa358b08-ca8c-4919-9217-59c11e977ed71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0049-3980-600004939806060 CAPSULE in 1 BOTTLE (0049-3980-60) 60 capsule2001-02-050000-00-00NoNoCurrent