FDA.reportPublic FDA data

Geodon

Product NDC
0049-3920
11-digit product format
000493920
Labeler code
0049
Product ID
0049-3920_c717f8ab-3351-4caa-b1fa-86c2fa415189
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone mesylate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
ROERIG
Application
NDA020919
Marketing category
NDA
Marketing start
2003-12-23
Marketing end
2026-08-31
Substance
ZIPRASIDONE MESYLATE
Active strength
20 mg/mL
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Geodon

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZIPRASIDONE MESYLATE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6UKA5VEJ6X, 216X081ORU, 3X6SAX83JZ
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
0049-3920-01Geodon1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,148
0049-3920-10Geodon10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1048
0049-3920-20Geodon1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,148
0049-3920-83Geodon10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1048

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0049-3920-01EA - Each0049-3920d518c0b4-07a8-4ac4-91ee-d3d56f1f749712024-08-12
0049-3920-10EA - Each0049-39207f385175-5b63-4b52-8861-29ce1db870bf12024-08-12
0049-3920-20EA - Each0049-3920e398770b-071b-4b43-842c-1c9ba28feb5312014-10-03
0049-3920-83EA - Each0049-3920eda90d66-bbcb-449e-9e74-82c3d4902cdc12012-07-24

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 MESYLATEACTIVE INGREDIENT3X6SAX83JZGEODON (ZIPRASIDONE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TYA PHARMACEUTICALS]2
ZIPRASIDONEACTIVE MOIETY6UKA5VEJ6XGEODON (ZIPRASIDONE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TYA PHARMACEUTICALS]2
METHANESULFONIC ACIDINACTIVE INGREDIENT12EH9M7279GEODON (ZIPRASIDONE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TYA PHARMACEUTICALS]2
SULFOBUTYLETHER .BETA.-CYCLODEXTRININACTIVE INGREDIENT2PP9364507GEODON (ZIPRASIDONE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0049-3920GEODON (ZIPRASIDONE HYDROCHLORIDE) CAPSULE GEODON (ZIPRASIDONE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GEODON (ZIPRASIDONE) CAPSULE [ROERIG]46Current NDC, Legacy NDC, 4 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
352228Geodon 20 MG InjectionPSN136aeec3-b918-4157-b2a7-dd615e36183f2
351223ziprasidone 20 MG InjectionPSN136aeec3-b918-4157-b2a7-dd615e36183f2
352228ziprasidone 20 MG Injection [Geodon]SBD136aeec3-b918-4157-b2a7-dd615e36183f2
351223ziprasidone 20 MG InjectionSCD136aeec3-b918-4157-b2a7-dd615e36183f2
352228Geodon (as ziprasidone mesylate) 20 MG InjectionSY136aeec3-b918-4157-b2a7-dd615e36183f2
352228Geodon 20 MG InjectionSY136aeec3-b918-4157-b2a7-dd615e36183f2
351223ziprasidone (as ziprasidone mesylate) 20 MG InjectionSY136aeec3-b918-4157-b2a7-dd615e36183f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0049-3920-01000493920011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
0049-3920-100004939201010 VIAL, SINGLE-DOSE in 1 CARTON (0049-3920-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0049-3920-01) 2024-07-242026-08-31NoNoHistorical
0049-3920-20000493920201 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
0049-3920-830004939208310 VIAL, SINGLE-DOSE in 1 CARTON (0049-3920-83) > 1 mL in 1 VIAL, SINGLE-DOSE (0049-3920-20) 2003-12-230000-00-00NoNoCurrent