ziprasidone

Product NDC
16714-838
11-digit product format
167140838
Labeler code
16714
Product ID
16714-838_cbe5f617-d390-54a0-2849-585abd37300f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone
Dosage form
CAPSULE
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA077565
Marketing category
ANDA
Marketing start
2018-07-26
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZIPRASIDONE HYDROCHLORIDE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii216X081ORU
Rxcui313778, 314286, 313776, 313777

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
defe29d6-6a09-c3aa-4400-b1130380ccc3Product name520231206
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-838-01ziprasidone60 in 1 BOTTLECAPSULE6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-838-01EA - Each16714-838c139a9ea-3507-426e-8281-3f40c9c677f712018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-838ZIPRASIDONE CAPSULE [NORTHSTAR RX LLC]9Current NDC, Legacy NDC, 1 package rows20250109_0071a228-21cc-56a6-dcc9-a7a6ceea758c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-838-011671408380160 CAPSULE in 1 BOTTLE (16714-838-01) 60 capsule2018-07-260000-00-00NoNoCurrent