ZIPRASIDONE MESYLATE

Product NDC
51662-1564
11-digit product format
516621564
Labeler code
51662
Product ID
51662-1564_1035b793-4301-3cb4-e063-6294a90a5b1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ZIPRASIDONE MESYLATE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA211908
Marketing category
ANDA
Marketing start
2021-07-17
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
51662-1564-2ZIPRASIDONE MESYLATE1 in 1 POUCHINJECTION, POWDER, LYOPHILIZED,12
51662-1564-2ZIPRASIDONE MESYLATE5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,52
51662-1564-3ZIPRASIDONE MESYLATE10 in 1 CASEINJECTION, POWDER, LYOPHILIZED,102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1564ZIPRASIDONE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]2Current NDC, Legacy NDC, 3 package rows20240201_c75971f8-9640-a6e8-e053-2995a90af654.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351223ziprasidone 20 MG InjectionPSNc75971f8-9640-a6e8-e053-2995a90af6542
351223ziprasidone 20 MG InjectionSCDc75971f8-9640-a6e8-e053-2995a90af6542
351223ziprasidone (as ziprasidone mesylate) 20 MG InjectionSYc75971f8-9640-a6e8-e053-2995a90af6542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1564-2516621564021 in 1 POUCHHistorical
51662-1564-35166215640310 POUCH in 1 CASE (51662-1564-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1564-2) / 5 mL in 1 VIAL, SINGLE-DOSE10 pouch2021-07-170000-00-00NoNoCurrent