FDA.reportPublic FDA data

Ziprasidone Hydrochloride

Product NDC
63629-3331
11-digit product format
636293331
Labeler code
63629
Product ID
63629-3331_3e3f03f9-e3d1-493d-b3d7-1f8215d6a9ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204375
Marketing category
ANDA
Marketing start
2017-02-18
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ziprasidone Hydrochloride
Listing expiration
2026-12-31

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
63629-3331-1Ziprasidone Hydrochloride60 in 1 BOTTLECAPSULE60104
63629-3331-2Ziprasidone Hydrochloride28 in 1 BOTTLECAPSULE28104
63629-3331-3Ziprasidone Hydrochloride30 in 1 BOTTLECAPSULE30104
63629-3331-4Ziprasidone Hydrochloride90 in 1 BOTTLECAPSULE90104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-3331ZIPRASIDONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 4 package rows20231026_fa70291d-8455-40d6-9b73-bf91880f9979.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313776ziprasidone HCl 40 MG Oral CapsulePSNfa70291d-8455-40d6-9b73-bf91880f9979104
313776ziprasidone 40 MG Oral CapsuleSCDfa70291d-8455-40d6-9b73-bf91880f9979104
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSYfa70291d-8455-40d6-9b73-bf91880f9979104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3331-16362933310160 CAPSULE in 1 BOTTLE (63629-3331-1) 60 capsule2022-03-080000-00-00NoNoCurrent
63629-3331-26362933310228 CAPSULE in 1 BOTTLE (63629-3331-2) 28 capsule2022-03-080000-00-00NoNoCurrent
63629-3331-36362933310330 CAPSULE in 1 BOTTLE (63629-3331-3) 30 capsule2021-05-140000-00-00NoNoCurrent
63629-3331-46362933310490 CAPSULE in 1 BOTTLE (63629-3331-4) 90 capsule2022-01-200000-00-00NoNoCurrent