Ziprasidone Mesylate

Product NDC
82449-004
11-digit product format
824490004
Labeler code
82449
Product ID
82449-004_3eebc107-3b95-1b1e-e063-6394a90afed2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone mesylate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
STERISCIENCE SPECIALTIES PRIVATE LIMITED
Application
ANDA217595
Marketing category
ANDA
Marketing start
2025-12-19
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
82449-004-01Ziprasidone Mesylate1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11
82449-004-01Ziprasidone Mesylate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,11
82449-004-02Ziprasidone Mesylate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,11
82449-004-02Ziprasidone Mesylate10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351223ziprasidone 20 MG InjectionPSN1ffd16c3-25ac-4839-9ea9-4efd32926b951
351223ziprasidone 20 MG InjectionSCD1ffd16c3-25ac-4839-9ea9-4efd32926b951
351223ziprasidone (as ziprasidone mesylate) 20 MG InjectionSY1ffd16c3-25ac-4839-9ea9-4efd32926b951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82449-004-01824490004011 VIAL, SINGLE-DOSE in 1 CARTON (82449-004-01) / 1 mL in 1 VIAL, SINGLE-DOSE2025-12-19NoNoHistorical
82449-004-028244900040210 VIAL, SINGLE-DOSE in 1 CARTON (82449-004-02) / 1 mL in 1 VIAL, SINGLE-DOSE2025-12-19NoNoHistorical