ziprasidone hydrochloride

Product NDC: 64725-0259
11-digit product format: 647250259
Labeler code: 64725
Product ID: 64725-0259_d91c0167-00cf-44e5-8d0f-0629b5241bfa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ziprasidone hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: TYA Pharmaceuticals
Application: ANDA077565
Marketing category: ANDA
Marketing start: 2012-03-02
Marketing end: 0000-00-00
Substance: ZIPRASIDONE HYDROCHLORIDE
Active strength: 80 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	64725-0259		I	Inactivated by FDA		2026-10-05
excluded package	package	64725-0259	64725-0259-1	I	Inactivated by FDA		2026-10-05

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64725-0259-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64725-0259-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64725-0259-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64725-0259-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64725-0259-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64725-0259-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64725-0259-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64725-0259-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64725-0259-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64725-0259-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64725-0259-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64725-0259-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64725-0259-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64725-0259-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64725-0259-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	64725-0259-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	64725-0259-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	64725-0259-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	64725-0259-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	64725-0259-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	64725-0259-1	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	64725-0259-1	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077565-001	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-03-02
A077565-002	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-03-02
A077565-003	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-03-02
A077565-004	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-03-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077565-001	AB
A077565-002	AB
A077565-003	AB
A077565-004	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 · 172 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
2026-09-14 22:38:34	2026-08	A077565-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-03-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077565-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-03-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077565-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-03-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077565-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-03-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077565-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077565-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077565-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077565-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-03-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077565-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077565-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077565-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077565-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-03-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077565-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077565-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077565-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077565-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-03-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077565-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077565-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077565-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077565-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-03-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077565-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077565-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077565-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077565-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-03-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077565-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077565-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077565-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077565-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-03-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077565-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077565-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077565-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077565-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-03-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077565-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077565-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077565-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077565-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-03-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077565-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-03-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077565-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-03-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077565-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-03-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077565-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-03-02	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077565-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077565-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077565-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077565-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077565-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077565-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077565-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077565-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077565-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077565-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077565-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077565-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077565-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077565-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077565-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077565-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077565-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077565-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077565-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077565-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077565-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077565-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077565-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077565-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077565-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077565-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077565-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077565-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077565-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077565-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077565-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077565-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077565-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077565-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077565-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077565-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077565-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077565-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077565-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077565-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64725-0259-1	2019-11-27	C162847	48780-1	9855e2a2-3321-60a7-e053-dbdaa90a05bd	These highlights do not include all the information needed to use ziprasidone safely and effectively. See full prescribing information for ziprasidone. Ziprasidone Hydrochloride Capsules for Oral use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64725-0259-1	ziprasidone hydrochloride	60 in 1 BOTTLE	CAPSULE	60		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ziprasidone hydrochloride	ACTIVE INGREDIENT	216X081ORU	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3
ziprasidone	ACTIVE MOIETY	6UKA5VEJ6X	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64725-0259	ZIPRASIDONE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]	3	Legacy NDC, 1 package rows	20140927_e05f08d9-682b-4113-bfa1-d0e351e30fa1.zip

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ziprasidone	ZIPRASIDONE	REMEDYREPACK INC.	6665279a-32ab-43ce-a258-039a6779a1a2	2026-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077565 application number: ANDA077565
ziprasidone	ZIPRASIDONE	REMEDYREPACK INC.	3834670f-cc31-4ed9-87ec-b631339ae18a	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077565 application number: ANDA077565
ziprasidone hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	5d576819-cd14-4a61-8a2f-6b90d8eac07e	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077565 application number: ANDA077565
ziprasidone	ZIPRASIDONE	REMEDYREPACK INC.	48b54613-9b5f-4fcb-ba1f-22085ee0d8d1	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077565 application number: ANDA077565
Ziprasidone	ZIPRASIDONE	Major Pharmaceuticals	ca55c149-5b9a-4144-b586-37cb5e84dc4e	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077565 application number: ANDA077565
ziprasidone	ZIPRASIDONE	Dr. Reddy's Laboratories Limited	396cb4a6-01a1-f73f-2a37-39df9067bf98	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077565 application number: ANDA077565
ziprasidone	ZIPRASIDONE	NorthStar Rx LLC	0071a228-21cc-56a6-dcc9-a7a6ceea758c	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077565 application number: ANDA077565
ziprasidone hydrochloride	ZIPRASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	56370be6-42a2-4962-acdc-22b7c6e0e7fe	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077565 application number: ANDA077565
ziprasidone hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	14191e0d-8219-4f6e-b808-09c4804a8262	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077565 application number: ANDA077565
ziprasidone hydrochloride	ZIPRASIDONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fc9ffbc3-1f16-9265-e053-6294a90acfd2	2025-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077565 application number: ANDA077565
ziprasidone hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	48e6e141-66d3-4eab-b0bf-dfd1d44b4832	2023-09-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077565 application number: ANDA077565

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
313778	ziprasidone HCl 80 MG Oral Capsule	PSN	e05f08d9-682b-4113-bfa1-d0e351e30fa1	3
313778	ziprasidone 80 MG Oral Capsule	SCD	e05f08d9-682b-4113-bfa1-d0e351e30fa1	3
313778	ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral Capsule	SY	e05f08d9-682b-4113-bfa1-d0e351e30fa1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
64725-0259-1	64725025901	60 in 1 BOTTLE	Historical