ziprasidone hydrochloride

Product NDC
70518-2294
11-digit product format
705182294
Labeler code
70518
Product ID
70518-2294_52564e2f-97e6-89ba-e063-6394a90ab424
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077565
Marketing category
ANDA
Marketing start
2019-09-03
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
40 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 HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii216X081ORU
Rxcui313776

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
70518-2294-0ziprasidone hydrochloride30 in 1 BLISTER PACKCAPSULE3018
70518-2294-1ziprasidone hydrochloride30 in 1 BOXCAPSULE3018
70518-2294-2ziprasidone hydrochloride1 in 1 POUCHCAPSULE118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2294ZIPRASIDONE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 3 package rows20250311_7e7261d7-4902-4bb5-a268-6c358890f963.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313776ziprasidone HCl 40 MG Oral CapsulePSN7e7261d7-4902-4bb5-a268-6c358890f96318
313776ziprasidone 40 MG Oral CapsuleSCD7e7261d7-4902-4bb5-a268-6c358890f96318
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSY7e7261d7-4902-4bb5-a268-6c358890f96318

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2294-07051822940030 CAPSULE in 1 BLISTER PACK (70518-2294-0) 30 capsule2019-09-030000-00-00NoNoCurrent
70518-2294-17051822940130 POUCH in 1 BOX (70518-2294-1) / 1 CAPSULE in 1 POUCH (70518-2294-2) 30 pouch2019-10-210000-00-00NoNoCurrent
70518-2294-2705182294021 in 1 POUCHHistorical