ziprasidone hydrochloride

Product NDC: 71335-1508
11-digit product format: 713351508
Labeler code: 71335
Product ID: 71335-1508_44534c80-f9dc-4e97-82b1-c8fbebb2b21f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ziprasidone hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA077565
Marketing category: ANDA
Marketing start: 2012-03-02
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71335-1508-1	ziprasidone hydrochloride	60 in 1 BOTTLE	CAPSULE	60		6
71335-1508-2	ziprasidone hydrochloride	30 in 1 BOTTLE	CAPSULE	30		6
71335-1508-3	ziprasidone hydrochloride	28 in 1 BOTTLE	CAPSULE	28		6
71335-1508-4	ziprasidone hydrochloride	90 in 1 BOTTLE	CAPSULE	90		6

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313778	ziprasidone HCl 80 MG Oral Capsule	PSN	14191e0d-8219-4f6e-b808-09c4804a8262	6
313778	ziprasidone 80 MG Oral Capsule	SCD	14191e0d-8219-4f6e-b808-09c4804a8262	6
313778	ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral Capsule	SY	14191e0d-8219-4f6e-b808-09c4804a8262	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1508-1	71335150801	60 CAPSULE in 1 BOTTLE (71335-1508-1)	60 capsule	2019-05-02	0000-00-00	No	No	Current
71335-1508-2	71335150802	30 CAPSULE in 1 BOTTLE (71335-1508-2)	30 capsule	2019-05-02	0000-00-00	No	No	Current
71335-1508-3	71335150803	28 CAPSULE in 1 BOTTLE (71335-1508-3)	28 capsule	2019-05-02	0000-00-00	No	No	Current
71335-1508-4	71335150804	90 CAPSULE in 1 BOTTLE (71335-1508-4)	90 capsule	2019-05-02	0000-00-00	No	No	Current