FDA.reportPublic FDA data

Ziprasidone

Product NDC
62135-994
11-digit product format
621350994
Labeler code
62135
Product ID
62135-994_02591199-8759-8e40-e063-6294a90afa7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone
Dosage form
CAPSULE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA090348
Marketing category
ANDA
Marketing start
2012-09-05
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
80 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZIPRASIDONE HYDROCHLORIDE80 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
62135-994-60Ziprasidone60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-994-60EA - Each62135-99446abee29-d62c-4b16-a2cb-23debf159d0112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-994ZIPRASIDONE CAPSULE ZIPRASIDONE (ZIPRASIDONE) CAPSULE [CHARTWELL RX, LLC]2Current NDC, 1 package rows20230808_7fbd9460-78a3-4160-9986-3a113de752a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314286ziprasidone HCl 20 MG Oral CapsulePSN7fbd9460-78a3-4160-9986-3a113de752a62
313776ziprasidone HCl 40 MG Oral CapsulePSN7fbd9460-78a3-4160-9986-3a113de752a62
313777ziprasidone HCl 60 MG Oral CapsulePSN7fbd9460-78a3-4160-9986-3a113de752a62
313778ziprasidone HCl 80 MG Oral CapsulePSN7fbd9460-78a3-4160-9986-3a113de752a62
314286ziprasidone 20 MG Oral CapsuleSCD7fbd9460-78a3-4160-9986-3a113de752a62
313776ziprasidone 40 MG Oral CapsuleSCD7fbd9460-78a3-4160-9986-3a113de752a62
313777ziprasidone 60 MG Oral CapsuleSCD7fbd9460-78a3-4160-9986-3a113de752a62
313778ziprasidone 80 MG Oral CapsuleSCD7fbd9460-78a3-4160-9986-3a113de752a62
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSY7fbd9460-78a3-4160-9986-3a113de752a62
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSY7fbd9460-78a3-4160-9986-3a113de752a62
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSY7fbd9460-78a3-4160-9986-3a113de752a62
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSY7fbd9460-78a3-4160-9986-3a113de752a62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-994-606213509946060 CAPSULE in 1 BOTTLE (62135-994-60) 60 capsule2023-04-28NoNoCurrent