FDA.reportPublic FDA data

Geodon

Product NDC
0049-0352
11-digit product format
000490352
Labeler code
0049
Product ID
0049-0352_c717f8ab-3351-4caa-b1fa-86c2fa415189
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone
Dosage form
CAPSULE
Route
ORAL
Labeler
ROERIG
Application
NDA020825
Marketing category
NDA
Marketing start
2021-11-08
Substance
ZIPRASIDONE
Active strength
20 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
Geodon
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZIPRASIDONE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3X6SAX83JZ, 6UKA5VEJ6X, 216X081ORU
Rxcui284548, 284549, 284550, 285127, 313776, 313777, 313778, 314286, 351223, 352228

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
0049-0352-60Geodon60 in 1 BOTTLECAPSULE6048

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0049-0352-60EA - Each0049-03522c894bc1-1e32-4bd1-9dbd-00879b60f56a12021-12-08

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0049-0352GEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE GEODON (ZIPRASIDONE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GEODON (ZIPRASIDONE) CAPSULE [ROERIG]46Current NDC, Legacy 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0049-0352-600004903526060 CAPSULE in 1 BOTTLE (0049-0352-60) 60 capsule2021-11-080000-00-00NoNoCurrent