FDA.reportPublic FDA data

ziprasidone hydrochloride

Product NDC
50268-813
11-digit product format
502680813
Labeler code
50268
Product ID
50268-813_4837897c-231e-1f6b-e063-6294a90a291c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA077561
Marketing category
ANDA
Marketing start
2021-05-12
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
60 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 HYDROCHLORIDE60 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
50268-813-11ziprasidone hydrochloride1 in 1 BLISTER PACKCAPSULE14
50268-813-12ziprasidone hydrochloride20 in 1 BOXCAPSULE204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-813-11EA - Each50268-813bd7a0b6e-3b51-4d67-a41c-c1284e53b65912021-06-02
50268-813-12EA - Each50268-813ed9875fe-6194-46fe-b86a-15dd9d69d48712021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-813ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AVPAK]3Current NDC, Legacy NDC, 2 package rows20240110_c227a618-1274-2b4d-e053-2a95a90a74fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314286ziprasidone HCl 20 MG Oral CapsulePSNc227a618-1274-2b4d-e053-2a95a90a74fb4
313776ziprasidone HCl 40 MG Oral CapsulePSNc227a618-1274-2b4d-e053-2a95a90a74fb4
313777ziprasidone HCl 60 MG Oral CapsulePSNc227a618-1274-2b4d-e053-2a95a90a74fb4
313778ziprasidone HCl 80 MG Oral CapsulePSNc227a618-1274-2b4d-e053-2a95a90a74fb4
314286ziprasidone 20 MG Oral CapsuleSCDc227a618-1274-2b4d-e053-2a95a90a74fb4
313776ziprasidone 40 MG Oral CapsuleSCDc227a618-1274-2b4d-e053-2a95a90a74fb4
313777ziprasidone 60 MG Oral CapsuleSCDc227a618-1274-2b4d-e053-2a95a90a74fb4
313778ziprasidone 80 MG Oral CapsuleSCDc227a618-1274-2b4d-e053-2a95a90a74fb4
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSYc227a618-1274-2b4d-e053-2a95a90a74fb4
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSYc227a618-1274-2b4d-e053-2a95a90a74fb4
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSYc227a618-1274-2b4d-e053-2a95a90a74fb4
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSYc227a618-1274-2b4d-e053-2a95a90a74fb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-813-11502680813111 in 1 BLISTER PACKHistorical
50268-813-125026808131220 BLISTER PACK in 1 BOX (50268-813-12) / 1 CAPSULE in 1 BLISTER PACK (50268-813-11) 20 blister pack2021-05-120000-00-00NoNoCurrent