Ziprasidone Hydrochloride

Product NDC: 71335-0501
11-digit product format: 713350501
Labeler code: 71335
Product ID: 71335-0501_c6cc71e8-9f79-4881-8721-0c105d6384cc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ziprasidone Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA204375
Marketing category: ANDA
Marketing start: 2017-02-18
Substance: ZIPRASIDONE HYDROCHLORIDE
Active strength: 80 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
Ingredient	Strength
ZIPRASIDONE HYDROCHLORIDE	80 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	216X081ORU
Rxcui	313778

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
defe29d6-6a09-c3aa-4400-b1130380ccc3	Product name	5	20231206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71335-0501-1	Ziprasidone Hydrochloride	60 in 1 BOTTLE	CAPSULE	60		13
71335-0501-2	Ziprasidone Hydrochloride	30 in 1 BOTTLE	CAPSULE	30		13
71335-0501-3	Ziprasidone Hydrochloride	28 in 1 BOTTLE	CAPSULE	28		13
71335-0501-4	Ziprasidone Hydrochloride	90 in 1 BOTTLE	CAPSULE	90		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0501-1	EA - Each	71335-0501	8c19ac65-0777-4c7c-8475-e182239990e5	1	2018-03-08
71335-0501-2	EA - Each	71335-0501	6096d338-ed86-4451-b162-cff29d31d77b	1	2018-03-08
71335-0501-3	EA - Each	71335-0501	6fd71f58-651a-4a80-b62c-9f17b76af12e	1	2018-03-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313778	ziprasidone HCl 80 MG Oral Capsule	PSN	7c683604-b827-434d-aff3-ee2ed0565cd7	13
313778	ziprasidone 80 MG Oral Capsule	SCD	7c683604-b827-434d-aff3-ee2ed0565cd7	13
313778	ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral Capsule	SY	7c683604-b827-434d-aff3-ee2ed0565cd7	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0501-1	71335050101	60 CAPSULE in 1 BOTTLE (71335-0501-1)	60 capsule	2018-05-22	0000-00-00	No	No	Current
71335-0501-2	71335050102	30 CAPSULE in 1 BOTTLE (71335-0501-2)	30 capsule	2019-09-05	0000-00-00	No	No	Current
71335-0501-3	71335050103	28 CAPSULE in 1 BOTTLE (71335-0501-3)	28 capsule	2022-06-28	0000-00-00	No	No	Current
71335-0501-4	71335050104	90 CAPSULE in 1 BOTTLE (71335-0501-4)	90 capsule	2022-06-28	0000-00-00	No	No	Current