Ziprasidone Hydrochloride

Product NDC
70518-0787
11-digit product format
705180787
Labeler code
70518
Product ID
70518-0787_4b312260-703f-713e-e063-6294a90a17f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204375
Marketing category
ANDA
Marketing start
2017-10-13
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
70518-0787-0Ziprasidone Hydrochloride30 in 1 BLISTER PACKCAPSULE3018
70518-0787-1Ziprasidone Hydrochloride30 in 1 BOXCAPSULE3018
70518-0787-2Ziprasidone Hydrochloride1 in 1 POUCHCAPSULE118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0787ZIPRASIDONE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 3 package rows20250502_c9f8f635-cf3f-4c42-8bd1-45bbe19bf97e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313776ziprasidone HCl 40 MG Oral CapsulePSNc9f8f635-cf3f-4c42-8bd1-45bbe19bf97e18
313776ziprasidone 40 MG Oral CapsuleSCDc9f8f635-cf3f-4c42-8bd1-45bbe19bf97e18
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSYc9f8f635-cf3f-4c42-8bd1-45bbe19bf97e18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0787-07051807870030 CAPSULE in 1 BLISTER PACK (70518-0787-0) 30 capsule2017-10-130000-00-00NoNoCurrent
70518-0787-17051807870130 POUCH in 1 BOX (70518-0787-1) / 1 CAPSULE in 1 POUCH (70518-0787-2) 30 pouch2021-07-280000-00-00NoNoCurrent
70518-0787-2705180787021 in 1 POUCHHistorical