FDA.reportPublic FDA data

Ziprasidone Hydrochloride

Product NDC
33342-146
11-digit product format
333420146
Labeler code
33342
Product ID
33342-146_a28d3d06-0479-4c6a-9e92-34b4ef776ac2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA204375
Marketing category
ANDA
Marketing start
2017-02-18
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
60 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 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
33342-146-09Ziprasidone Hydrochloride60 in 1 BOTTLECAPSULE607
33342-146-12Ziprasidone Hydrochloride10 in 1 BLISTER PACKCAPSULE107
33342-146-12Ziprasidone Hydrochloride10 in 1 CARTONCAPSULE107
33342-146-51Ziprasidone Hydrochloride300 in 1 BOTTLECAPSULE3007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-146-09EA - Each33342-1467299b079-234b-4b62-87c6-0450025fb01e12017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-146ZIPRASIDONE HYDROCHLORIDE CAPSULE [MACLEODS PHARMACEUTICALS LIMITED]7Current NDC, Legacy NDC, 4 package rows20230418_3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313777ziprasidone HCl 60 MG Oral CapsulePSN798631b6-b9d9-44de-9a1a-ae2cee86d531103
313777ziprasidone 60 MG Oral CapsuleSCD798631b6-b9d9-44de-9a1a-ae2cee86d531103
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSY798631b6-b9d9-44de-9a1a-ae2cee86d531103
313777ziprasidone HCl 60 MG Oral CapsulePSNa66a0b25-673c-4a3d-b923-5f65a02b8ff015
313777ziprasidone 60 MG Oral CapsuleSCDa66a0b25-673c-4a3d-b923-5f65a02b8ff015
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSYa66a0b25-673c-4a3d-b923-5f65a02b8ff015
314286ziprasidone HCl 20 MG Oral CapsulePSN3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af07
313776ziprasidone HCl 40 MG Oral CapsulePSN3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af07
313777ziprasidone HCl 60 MG Oral CapsulePSN3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af07
313778ziprasidone HCl 80 MG Oral CapsulePSN3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af07
314286ziprasidone 20 MG Oral CapsuleSCD3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af07
313776ziprasidone 40 MG Oral CapsuleSCD3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af07
313777ziprasidone 60 MG Oral CapsuleSCD3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af07
313778ziprasidone 80 MG Oral CapsuleSCD3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af07
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSY3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af07
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSY3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af07
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSY3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af07
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSY3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-146-093334201460960 CAPSULE in 1 BOTTLE (33342-146-09) 60 capsule2017-02-180000-00-00NoNoCurrent
33342-146-123334201461210 BLISTER PACK in 1 CARTON (33342-146-12) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2017-02-180000-00-00NoNoCurrent
33342-146-5133342014651300 CAPSULE in 1 BOTTLE (33342-146-51) 300 capsule2017-02-180000-00-00NoNoCurrent