ziprasidone

Product NDC
70518-4475
11-digit product format
705184475
Labeler code
70518
Product ID
70518-4475_5268eb27-7ee8-e1de-e063-6294a90a96ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077565
Marketing category
ANDA
Marketing start
2025-09-11
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
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4475-0ziprasidone30 in 1 BLISTER PACKCAPSULE303
70518-4475-1ziprasidone30 in 1 BOXCAPSULE303
70518-4475-2ziprasidone1 in 1 POUCHCAPSULE13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313777ziprasidone HCl 60 MG Oral CapsulePSN48b54613-9b5f-4fcb-ba1f-22085ee0d8d13
313777ziprasidone 60 MG Oral CapsuleSCD48b54613-9b5f-4fcb-ba1f-22085ee0d8d13
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSY48b54613-9b5f-4fcb-ba1f-22085ee0d8d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4475-07051844750030 CAPSULE in 1 BLISTER PACK (70518-4475-0) 30 capsule2025-09-11NoNoHistorical
70518-4475-17051844750130 POUCH in 1 BOX (70518-4475-1) / 1 CAPSULE in 1 POUCH (70518-4475-2) 30 pouch2025-10-10NoNoHistorical
70518-4475-2705184475021 in 1 POUCHHistorical