FDA.reportPublic FDA data

ziprasidone mesylate

Product NDC
43598-061
11-digit product format
435980061
Labeler code
43598
Product ID
43598-061_b94a787b-0592-ac3d-b887-c706d571f6e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone mesylate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
Dr.Reddy's Laboratories, Inc.
Application
ANDA211908
Marketing category
ANDA
Marketing start
2022-03-22
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
43598-061-11ziprasidone mesylate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,12
43598-061-58ziprasidone mesylate1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-061-11EA - Each43598-06135ef85ad-4330-4b1c-9a31-cfa549440cd412022-05-04
43598-061-58EA - Each43598-0614b0ce51e-1c2b-40a0-92ef-31e0f33c511612022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-061ZIPRASIDONE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR.REDDY'S LABORATORIES, INC. ]2Current NDC, Legacy NDC, 2 package rows20220831_6fd6fc45-20c4-e223-3532-ce37aa02b71c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351223ziprasidone 20 MG InjectionPSN6fd6fc45-20c4-e223-3532-ce37aa02b71c2
351223ziprasidone 20 MG InjectionSCD6fd6fc45-20c4-e223-3532-ce37aa02b71c2
351223ziprasidone (as ziprasidone mesylate) 20 MG InjectionSY6fd6fc45-20c4-e223-3532-ce37aa02b71c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-061-11435980061111 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
43598-061-58435980061581 VIAL, SINGLE-DOSE in 1 CARTON (43598-061-58) / 1 mL in 1 VIAL, SINGLE-DOSE (43598-061-11) 2022-03-220000-00-00NoNoCurrent