FDA.reportPublic FDA data

Geodon

Product NDC
21695-060
11-digit product format
216950060
Labeler code
21695
Product ID
21695-060_a3aa96bb-2cc1-4316-b94c-61593e927505
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA020825
Marketing category
NDA
Marketing start
2001-02-05
Marketing end
0000-00-00
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
21695-060-102019-09-24C16284748780-1934fe258-4c41-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use GEODON safely and effectively. See full prescribing information for GEODON. GEODON (ziprasidone HCl) capsules GEODON (ziprasidone mesylate) injection for intramuscular use Initial U.S. Approval: 2001
21695-060-152019-09-24C16284748780-1934fe258-4c41-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use GEODON safely and effectively. See full prescribing information for GEODON. GEODON (ziprasidone HCl) capsules GEODON (ziprasidone mesylate) injection for intramuscular use Initial U.S. Approval: 2001
21695-060-452019-09-24C16284748780-1934fe258-4c41-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use GEODON safely and effectively. See full prescribing information for GEODON. GEODON (ziprasidone HCl) capsules GEODON (ziprasidone mesylate) injection for intramuscular use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-060-10Geodon10 in 1 BOTTLECAPSULE101
21695-060-15Geodon15 in 1 BOTTLECAPSULE151
21695-060-45Geodon45 in 1 BOTTLECAPSULE451

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-060-10EA - Each21695-060efdcb9c5-abd6-4cb2-b6d0-719510e548e212012-07-24
21695-060-15EA - Each21695-0602acfc1c3-cb18-43ba-bd82-46f4b74e5f7e12012-07-24
21695-060-45EA - Each21695-060030668ed-b66c-4199-abcf-46625e1c3e2c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ziprasidone hydrochlorideACTIVE INGREDIENT216X081ORUGEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
ziprasidoneACTIVE MOIETY6UKA5VEJ6XGEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
lactoseINACTIVE INGREDIENTJ2B2A4N98GGEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30GEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-060GEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 3 package rows20101126_a3aa96bb-2cc1-4316-b94c-61593e927505.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
285127Geodon 20 MG Oral CapsulePSNa3aa96bb-2cc1-4316-b94c-61593e9275051
284548Geodon 40 MG Oral CapsulePSNa3aa96bb-2cc1-4316-b94c-61593e9275051
284549Geodon 60 MG Oral CapsulePSNa3aa96bb-2cc1-4316-b94c-61593e9275051
284550Geodon 80 MG Oral CapsulePSNa3aa96bb-2cc1-4316-b94c-61593e9275051
314286ziprasidone HCl 20 MG Oral CapsulePSNa3aa96bb-2cc1-4316-b94c-61593e9275051
313776ziprasidone HCl 40 MG Oral CapsulePSNa3aa96bb-2cc1-4316-b94c-61593e9275051
313777ziprasidone HCl 60 MG Oral CapsulePSNa3aa96bb-2cc1-4316-b94c-61593e9275051
313778ziprasidone HCl 80 MG Oral CapsulePSNa3aa96bb-2cc1-4316-b94c-61593e9275051
285127ziprasidone 20 MG Oral Capsule [Geodon]SBDa3aa96bb-2cc1-4316-b94c-61593e9275051
284548ziprasidone 40 MG Oral Capsule [Geodon]SBDa3aa96bb-2cc1-4316-b94c-61593e9275051
284549ziprasidone 60 MG Oral Capsule [Geodon]SBDa3aa96bb-2cc1-4316-b94c-61593e9275051
284550ziprasidone 80 MG Oral Capsule [Geodon]SBDa3aa96bb-2cc1-4316-b94c-61593e9275051
314286ziprasidone 20 MG Oral CapsuleSCDa3aa96bb-2cc1-4316-b94c-61593e9275051
313776ziprasidone 40 MG Oral CapsuleSCDa3aa96bb-2cc1-4316-b94c-61593e9275051
313777ziprasidone 60 MG Oral CapsuleSCDa3aa96bb-2cc1-4316-b94c-61593e9275051
313778ziprasidone 80 MG Oral CapsuleSCDa3aa96bb-2cc1-4316-b94c-61593e9275051
285127Geodon (as ziprasidone hydrochloride monohydrate) 20 MG Oral CapsuleSYa3aa96bb-2cc1-4316-b94c-61593e9275051
284548Geodon (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSYa3aa96bb-2cc1-4316-b94c-61593e9275051
284549Geodon (as ziprasidone hydrochloride monohydrate) 60 MG Oral CapsuleSYa3aa96bb-2cc1-4316-b94c-61593e9275051
284550Geodon (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSYa3aa96bb-2cc1-4316-b94c-61593e9275051
285127Geodon 20 MG Oral CapsuleSYa3aa96bb-2cc1-4316-b94c-61593e9275051
284548Geodon 40 MG Oral CapsuleSYa3aa96bb-2cc1-4316-b94c-61593e9275051
284549Geodon 60 MG Oral CapsuleSYa3aa96bb-2cc1-4316-b94c-61593e9275051
284550Geodon 80 MG Oral CapsuleSYa3aa96bb-2cc1-4316-b94c-61593e9275051
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSYa3aa96bb-2cc1-4316-b94c-61593e9275051
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSYa3aa96bb-2cc1-4316-b94c-61593e9275051
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSYa3aa96bb-2cc1-4316-b94c-61593e9275051
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSYa3aa96bb-2cc1-4316-b94c-61593e9275051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-060-102169500601010 in 1 BOTTLEHistorical
21695-060-152169500601515 in 1 BOTTLEHistorical
21695-060-452169500604545 in 1 BOTTLEHistorical