FDA.reportPublic FDA data

ziprasidone hydrochloride

Product NDC
70518-1835
11-digit product format
705181835
Labeler code
70518
Product ID
70518-1835_52546585-9131-4b54-e063-6294a90aaeec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077565
Marketing category
ANDA
Marketing start
2019-01-30
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
20 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 HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii216X081ORU
Rxcui314286

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
70518-1835-0ziprasidone hydrochloride30 in 1 BLISTER PACKCAPSULE3017
70518-1835-1ziprasidone hydrochloride30 in 1 BOXCAPSULE3017
70518-1835-2ziprasidone hydrochloride1 in 1 POUCHCAPSULE117
70518-1835-3ziprasidone hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE3017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1835ZIPRASIDONE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 4 package rows20250302_56370be6-42a2-4962-acdc-22b7c6e0e7fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314286ziprasidone HCl 20 MG Oral CapsulePSN56370be6-42a2-4962-acdc-22b7c6e0e7fe17
314286ziprasidone 20 MG Oral CapsuleSCD56370be6-42a2-4962-acdc-22b7c6e0e7fe17
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSY56370be6-42a2-4962-acdc-22b7c6e0e7fe17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1835-07051818350030 CAPSULE in 1 BLISTER PACK (70518-1835-0) 30 capsule2019-01-300000-00-00NoNoCurrent
70518-1835-17051818350130 POUCH in 1 BOX, UNIT-DOSE (70518-1835-1) > 1 CAPSULE in 1 POUCH (70518-1835-2) 30 pouch2019-10-210000-00-00NoNoCurrent
70518-1835-2705181835021 in 1 POUCHHistorical
70518-1835-37051818350330 in 1 BOTTLE, PLASTICHistorical