Ziprasidone hydrochloride

Product NDC: 64679-993
Requested package NDC: 64679-993-01
11-digit product format: 646790993
Labeler code: 64679
Product ID: 64679-993_83bb92ad-8d72-4b8d-958a-ff4c97c9c2ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ziprasidone hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Wockhardt USA LLC.
Application: ANDA090348
Marketing category: ANDA
Marketing start: 2012-09-01
Marketing end: 0000-00-00
Substance: ZIPRASIDONE HYDROCHLORIDE
Active strength: 60 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	64679-993	64679-993-01	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090348-001	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-09-05
A090348-002	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-09-05
A090348-003	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-09-05
A090348-004	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-09-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090348-001	AB
A090348-002	AB
A090348-003	AB
A090348-004	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090348-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090348-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090348-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090348-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090348-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090348-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090348-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090348-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090348-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090348-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090348-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090348-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090348-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090348-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090348-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090348-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090348-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090348-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090348-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090348-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090348-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090348-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090348-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090348-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090348-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090348-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090348-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090348-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090348-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090348-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090348-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090348-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090348-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090348-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090348-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090348-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-09-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090348-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-09-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090348-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-09-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090348-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-09-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090348-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-09-05	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090348-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090348-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090348-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090348-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090348-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090348-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090348-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090348-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090348-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090348-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090348-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090348-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090348-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090348-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090348-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090348-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090348-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090348-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090348-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090348-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090348-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090348-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090348-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090348-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090348-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090348-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090348-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090348-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090348-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090348-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090348-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090348-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090348-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090348-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090348-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090348-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090348-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090348-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090348-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090348-004	AB	1	`d06236e962d9…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
64679-993-01	2024-11-15	These highlights do not include all the information needed to use ZIPRASIDONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for ZIPRASIDONE HYDROCHLORIDE CAPSULES. ZIPRASIDONE hydrochloride capsules for oral use Initial U.S. Approval: 2001
64679-993-02	2024-11-15	These highlights do not include all the information needed to use ZIPRASIDONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for ZIPRASIDONE HYDROCHLORIDE CAPSULES. ZIPRASIDONE hydrochloride capsules for oral use Initial U.S. Approval: 2001
64679-993-03	2024-11-15	These highlights do not include all the information needed to use ZIPRASIDONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for ZIPRASIDONE HYDROCHLORIDE CAPSULES. ZIPRASIDONE hydrochloride capsules for oral use Initial U.S. Approval: 2001
64679-993-04	2024-11-15	These highlights do not include all the information needed to use ZIPRASIDONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for ZIPRASIDONE HYDROCHLORIDE CAPSULES. ZIPRASIDONE hydrochloride capsules for oral use Initial U.S. Approval: 2001
64679-993-06	2024-11-15	These highlights do not include all the information needed to use ZIPRASIDONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for ZIPRASIDONE HYDROCHLORIDE CAPSULES. ZIPRASIDONE hydrochloride capsules for oral use Initial U.S. Approval: 2001
64679-993-01	2022-01-28	These highlights do not include all the information needed to use ZIPRASIDONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for ZIPRASIDONE HYDROCHLORIDE CAPSULES. ZIPRASIDONE hydrochloride capsules for oral use Initial U.S. Approval: 2001
64679-993-02	2022-01-28	These highlights do not include all the information needed to use ZIPRASIDONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for ZIPRASIDONE HYDROCHLORIDE CAPSULES. ZIPRASIDONE hydrochloride capsules for oral use Initial U.S. Approval: 2001
64679-993-03	2022-01-28	These highlights do not include all the information needed to use ZIPRASIDONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for ZIPRASIDONE HYDROCHLORIDE CAPSULES. ZIPRASIDONE hydrochloride capsules for oral use Initial U.S. Approval: 2001
64679-993-04	2022-01-28	These highlights do not include all the information needed to use ZIPRASIDONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for ZIPRASIDONE HYDROCHLORIDE CAPSULES. ZIPRASIDONE hydrochloride capsules for oral use Initial U.S. Approval: 2001
64679-993-06	2022-01-28	These highlights do not include all the information needed to use ZIPRASIDONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for ZIPRASIDONE HYDROCHLORIDE CAPSULES. ZIPRASIDONE hydrochloride capsules for oral use Initial U.S. Approval: 2001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64679-993-02	EA - Each	64679-993	19045977-a4ed-4184-bbb4-652e1432f449	1	2013-02-13
64679-993-04	EA - Each	64679-993	59adf8f9-0633-4fd7-8337-b54e188d6810	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZIPRASIDONE HYDROCHLORIDE	ACTIVE INGREDIENT	216X081ORU	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	4
ZIPRASIDONE	ACTIVE MOIETY	6UKA5VEJ6X	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	4
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	4
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	4
ZIPRASIDONE HYDROCHLORIDE	ACTIVE INGREDIENT	216X081ORU	ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT USA LLC.]	2
ZIPRASIDONE	ACTIVE MOIETY	6UKA5VEJ6X	ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT USA LLC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT USA LLC.]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT USA LLC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT USA LLC.]	2
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT USA LLC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT USA LLC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT USA LLC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT USA LLC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT USA LLC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT USA LLC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT USA LLC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT USA LLC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT USA LLC.]	2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ziprasidone	ZIPRASIDONE	Chartwell RX, LLC	7fbd9460-78a3-4160-9986-3a113de752a6	2023-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090348 application number: ANDA090348

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
216X081ORU	ZIPRASIDONE HYDROCHLORIDE	138982-67-9	ZIPRASIDONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313777	ziprasidone HCl 60 MG Oral Capsule	PSN	4890cf77-8da3-46ae-b6f6-abea7aae6b4d	4
313778	ziprasidone HCl 80 MG Oral Capsule	PSN	4890cf77-8da3-46ae-b6f6-abea7aae6b4d	4
313777	ziprasidone 60 MG Oral Capsule	SCD	4890cf77-8da3-46ae-b6f6-abea7aae6b4d	4
313778	ziprasidone 80 MG Oral Capsule	SCD	4890cf77-8da3-46ae-b6f6-abea7aae6b4d	4
313777	ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral Capsule	SY	4890cf77-8da3-46ae-b6f6-abea7aae6b4d	4
313778	ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral Capsule	SY	4890cf77-8da3-46ae-b6f6-abea7aae6b4d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64679-993-01	64679099301	30 CAPSULE in 1 BOTTLE (64679-993-01)	30 capsule	2012-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ziprasidone hydrochloride	Wockhardt USA LLC. \| Wockhardt Limited	2019-11-26	HUMAN PRESCRIPTION DRUG LABEL	4
Ziprasidone hydrochloride	TYA Pharmaceuticals	2012-07-20	HUMAN PRESCRIPTION DRUG LABEL	4