FDA.reportPublic FDA data

Ziprasidone Hydrochloride

Product NDC
65862-703
11-digit product format
658620703
Labeler code
65862
Product ID
65862-703_7f518739-d6ea-4630-b7d5-45d78499149e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
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, 313777, 313778, 314286

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
65862-703-10Ziprasidone Hydrochloride10 in 1 BLISTER PACKCAPSULE1016
65862-703-60Ziprasidone Hydrochloride60 in 1 BOTTLECAPSULE6016
65862-703-80Ziprasidone Hydrochloride8 in 1 CARTONCAPSULE816
65862-703-99Ziprasidone Hydrochloride1000 in 1 BOTTLECAPSULE100016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-703ZIPRASIDONE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]16Current NDC, Legacy NDC, 4 package rows20250516_cc5e1c44-79e9-45d3-b1e5-b003f550c508.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314286ziprasidone HCl 20 MG Oral CapsulePSNcc5e1c44-79e9-45d3-b1e5-b003f550c50816
313776ziprasidone HCl 40 MG Oral CapsulePSNcc5e1c44-79e9-45d3-b1e5-b003f550c50816
313777ziprasidone HCl 60 MG Oral CapsulePSNcc5e1c44-79e9-45d3-b1e5-b003f550c50816
313778ziprasidone HCl 80 MG Oral CapsulePSNcc5e1c44-79e9-45d3-b1e5-b003f550c50816
314286ziprasidone 20 MG Oral CapsuleSCDcc5e1c44-79e9-45d3-b1e5-b003f550c50816
313776ziprasidone 40 MG Oral CapsuleSCDcc5e1c44-79e9-45d3-b1e5-b003f550c50816
313777ziprasidone 60 MG Oral CapsuleSCDcc5e1c44-79e9-45d3-b1e5-b003f550c50816
313778ziprasidone 80 MG Oral CapsuleSCDcc5e1c44-79e9-45d3-b1e5-b003f550c50816
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSYcc5e1c44-79e9-45d3-b1e5-b003f550c50816
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSYcc5e1c44-79e9-45d3-b1e5-b003f550c50816
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSYcc5e1c44-79e9-45d3-b1e5-b003f550c50816
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSYcc5e1c44-79e9-45d3-b1e5-b003f550c50816
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 startMarketing endSampleExclude flagStatus
65862-703-106586207031010 in 1 BLISTER PACKHistorical
65862-703-35658620703353500 CAPSULE in 1 BAG (65862-703-35)3500 capsule27-DEC-16Current
65862-703-606586207036060 CAPSULE in 1 BOTTLE (65862-703-60) 60 capsule2016-12-270000-00-00NoNoCurrent
65862-703-80658620703808 BLISTER PACK in 1 CARTON (65862-703-80) / 10 CAPSULE in 1 BLISTER PACK (65862-703-10) 8 blister pack2016-12-270000-00-00NoNoCurrent
65862-703-99658620703991000 CAPSULE in 1 BOTTLE (65862-703-99) 1000 capsule2016-12-270000-00-00NoNoCurrent