Ziprasidone Hydrochloride

Product NDC
68071-3563
11-digit product format
680713563
Labeler code
68071
Product ID
68071-3563_0fcead61-ddda-bcef-e063-6394a90af8a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA204117
Marketing category
ANDA
Marketing start
2016-12-27
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
68071-3563-3Ziprasidone Hydrochloride30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3563ZIPRASIDONE HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.]1Current NDC, 1 package rows20240126_0fcebd61-25b2-d287-e063-6394a90a7b9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313776ziprasidone HCl 40 MG Oral CapsulePSN0fcebd61-25b2-d287-e063-6394a90a7b9a1
313776ziprasidone 40 MG Oral CapsuleSCD0fcebd61-25b2-d287-e063-6394a90a7b9a1
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSY0fcebd61-25b2-d287-e063-6394a90a7b9a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3563-36807135630330 CAPSULE in 1 BOTTLE (68071-3563-3) 30 capsule2024-01-25NoNoCurrent