Ziprasidone Hydrochloride

Product NDC
70518-0782
11-digit product format
705180782
Labeler code
70518
Product ID
70518-0782_4dc6932d-4bcd-63aa-e063-6394a90a90fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204375
Marketing category
ANDA
Marketing start
2017-10-11
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
60 mg/1
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
Ziprasidone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZIPRASIDONE HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii216X081ORU
Rxcui313777

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
70518-0782-0Ziprasidone Hydrochloride30 in 1 BLISTER PACKCAPSULE3015
70518-0782-1Ziprasidone Hydrochloride30 in 1 BOXCAPSULE3015
70518-0782-2Ziprasidone Hydrochloride1 in 1 POUCHCAPSULE115

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0782ZIPRASIDONE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]12Current NDC, Legacy NDC, 3 package rows20250429_a66a0b25-673c-4a3d-b923-5f65a02b8ff0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313777ziprasidone HCl 60 MG Oral CapsulePSNa66a0b25-673c-4a3d-b923-5f65a02b8ff015
313777ziprasidone 60 MG Oral CapsuleSCDa66a0b25-673c-4a3d-b923-5f65a02b8ff015
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSYa66a0b25-673c-4a3d-b923-5f65a02b8ff015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0782-07051807820030 CAPSULE in 1 BLISTER PACK (70518-0782-0) 30 capsule2017-10-110000-00-00NoNoCurrent
70518-0782-17051807820130 POUCH in 1 BOX (70518-0782-1) / 1 CAPSULE in 1 POUCH (70518-0782-2) 30 pouch2025-03-24NoNoCurrent
70518-0782-2705180782021 in 1 POUCHHistorical