FDA.reportPublic FDA data

ziprasidone mesylate

Product NDC
72205-205
11-digit product format
722050205
Labeler code
72205
Product ID
72205-205_4e003e80-c860-4b03-81e2-6662324096d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone mesylate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA216091
Marketing category
ANDA
Marketing start
2022-09-15
Substance
ZIPRASIDONE MESYLATE
Active strength
20 mg/mL
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ziprasidone mesylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZIPRASIDONE MESYLATE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3X6SAX83JZ
Rxcui351223

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
72205-205-01ziprasidone mesylate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,12
72205-205-07ziprasidone mesylate10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-205-01EA - Each72205-2056f0ed70f-d34d-4ff6-b48c-9c6ec9718f3d12023-06-06
72205-205-07EA - Each72205-205e198e55f-c05f-4964-b9b7-fd70ba00750012023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-205ZIPRASIDONE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, Legacy NDC, 2 package rows20220920_90b35a26-ab65-4c39-b97f-55c8c0e34b0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351223ziprasidone 20 MG InjectionPSN90b35a26-ab65-4c39-b97f-55c8c0e34b0b2
351223ziprasidone 20 MG InjectionSCD90b35a26-ab65-4c39-b97f-55c8c0e34b0b2
351223ziprasidone (as ziprasidone mesylate) 20 MG InjectionSY90b35a26-ab65-4c39-b97f-55c8c0e34b0b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-205-01722050205011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
72205-205-077220502050710 VIAL, SINGLE-DOSE in 1 CARTON (72205-205-07) / 1 mL in 1 VIAL, SINGLE-DOSE (72205-205-01) 2022-09-150000-00-00NoNoCurrent