ziprasidone hydrochloride

Product NDC
70518-1604
11-digit product format
705181604
Labeler code
70518
Product ID
70518-1604_5253409b-a651-4404-e063-6294a90a0102
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077565
Marketing category
ANDA
Marketing start
2018-10-26
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
80 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 HYDROCHLORIDE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii216X081ORU
Rxcui313778

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
70518-1604-0ziprasidone hydrochloride30 in 1 BLISTER PACKCAPSULE3019
70518-1604-1ziprasidone hydrochloride30 in 1 BOXCAPSULE3019
70518-1604-2ziprasidone hydrochloride1 in 1 POUCHCAPSULE119

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1604ZIPRASIDONE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]15Current NDC, Legacy NDC, 3 package rows20250226_c8841b89-b451-4b7c-8110-6a3a58cb986a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313778ziprasidone HCl 80 MG Oral CapsulePSNc8841b89-b451-4b7c-8110-6a3a58cb986a19
313778ziprasidone 80 MG Oral CapsuleSCDc8841b89-b451-4b7c-8110-6a3a58cb986a19
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSYc8841b89-b451-4b7c-8110-6a3a58cb986a19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1604-07051816040030 CAPSULE in 1 BLISTER PACK (70518-1604-0) 30 capsule2018-10-260000-00-00NoNoCurrent
70518-1604-17051816040130 POUCH in 1 BOX (70518-1604-1) / 1 CAPSULE in 1 POUCH (70518-1604-2) 30 pouch2019-04-230000-00-00NoNoCurrent
70518-1604-2705181604021 in 1 POUCHHistorical