FDA.reportPublic FDA data

Geodon

Product NDC
58151-137
11-digit product format
581510137
Labeler code
58151
Product ID
58151-137_8351d3a9-c9f8-4ae0-be80-ae3a4ef02820
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone mesylate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
Viatris Specialty LLC
Application
NDA020919
Marketing category
NDA
Marketing start
2025-09-09
Substance
ZIPRASIDONE MESYLATE
Active strength
20 mg/mL
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
ZIPRASIDONE MESYLATE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3X6SAX83JZ, 6UKA5VEJ6X
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
58151-137-81Geodon10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,102
58151-137-81Geodon1 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-137-81EA - Each58151-137247cdf49-5ed3-426c-b1cf-f8ad9df4eba112025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
352228Geodon 20 MG InjectionPSNa2b4cc65-6a6d-49c4-adfc-a4458562a1672
285127Geodon 20 MG Oral CapsulePSNa2b4cc65-6a6d-49c4-adfc-a4458562a1672
284548Geodon 40 MG Oral CapsulePSNa2b4cc65-6a6d-49c4-adfc-a4458562a1672
284549Geodon 60 MG Oral CapsulePSNa2b4cc65-6a6d-49c4-adfc-a4458562a1672
284550Geodon 80 MG Oral CapsulePSNa2b4cc65-6a6d-49c4-adfc-a4458562a1672
351223ziprasidone 20 MG InjectionPSNa2b4cc65-6a6d-49c4-adfc-a4458562a1672
314286ziprasidone HCl 20 MG Oral CapsulePSNa2b4cc65-6a6d-49c4-adfc-a4458562a1672
313776ziprasidone HCl 40 MG Oral CapsulePSNa2b4cc65-6a6d-49c4-adfc-a4458562a1672
313777ziprasidone HCl 60 MG Oral CapsulePSNa2b4cc65-6a6d-49c4-adfc-a4458562a1672
313778ziprasidone HCl 80 MG Oral CapsulePSNa2b4cc65-6a6d-49c4-adfc-a4458562a1672
352228ziprasidone 20 MG Injection [Geodon]SBDa2b4cc65-6a6d-49c4-adfc-a4458562a1672
285127ziprasidone 20 MG Oral Capsule [Geodon]SBDa2b4cc65-6a6d-49c4-adfc-a4458562a1672
284548ziprasidone 40 MG Oral Capsule [Geodon]SBDa2b4cc65-6a6d-49c4-adfc-a4458562a1672
284549ziprasidone 60 MG Oral Capsule [Geodon]SBDa2b4cc65-6a6d-49c4-adfc-a4458562a1672
284550ziprasidone 80 MG Oral Capsule [Geodon]SBDa2b4cc65-6a6d-49c4-adfc-a4458562a1672
351223ziprasidone 20 MG InjectionSCDa2b4cc65-6a6d-49c4-adfc-a4458562a1672
314286ziprasidone 20 MG Oral CapsuleSCDa2b4cc65-6a6d-49c4-adfc-a4458562a1672
313776ziprasidone 40 MG Oral CapsuleSCDa2b4cc65-6a6d-49c4-adfc-a4458562a1672
313777ziprasidone 60 MG Oral CapsuleSCDa2b4cc65-6a6d-49c4-adfc-a4458562a1672
313778ziprasidone 80 MG Oral CapsuleSCDa2b4cc65-6a6d-49c4-adfc-a4458562a1672
285127Geodon (as ziprasidone hydrochloride monohydrate) 20 MG Oral CapsuleSYa2b4cc65-6a6d-49c4-adfc-a4458562a1672
284548Geodon (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSYa2b4cc65-6a6d-49c4-adfc-a4458562a1672
284549Geodon (as ziprasidone hydrochloride monohydrate) 60 MG Oral CapsuleSYa2b4cc65-6a6d-49c4-adfc-a4458562a1672
284550Geodon (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSYa2b4cc65-6a6d-49c4-adfc-a4458562a1672
352228Geodon (as ziprasidone mesylate) 20 MG InjectionSYa2b4cc65-6a6d-49c4-adfc-a4458562a1672
352228Geodon 20 MG InjectionSYa2b4cc65-6a6d-49c4-adfc-a4458562a1672
285127Geodon 20 MG Oral CapsuleSYa2b4cc65-6a6d-49c4-adfc-a4458562a1672
284548Geodon 40 MG Oral CapsuleSYa2b4cc65-6a6d-49c4-adfc-a4458562a1672
284549Geodon 60 MG Oral CapsuleSYa2b4cc65-6a6d-49c4-adfc-a4458562a1672
284550Geodon 80 MG Oral CapsuleSYa2b4cc65-6a6d-49c4-adfc-a4458562a1672
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSYa2b4cc65-6a6d-49c4-adfc-a4458562a1672
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSYa2b4cc65-6a6d-49c4-adfc-a4458562a1672
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSYa2b4cc65-6a6d-49c4-adfc-a4458562a1672
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSYa2b4cc65-6a6d-49c4-adfc-a4458562a1672
351223ziprasidone (as ziprasidone mesylate) 20 MG InjectionSYa2b4cc65-6a6d-49c4-adfc-a4458562a1672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58151-137-815815101378110 VIAL in 1 CARTON (58151-137-81) / 1 mL in 1 VIAL10 vial2025-09-09NoNoCurrent