Ziprasidone hydrochloride

Product NDC: 55648-992
11-digit product format: 556480992
Labeler code: 55648
Product ID: 55648-992_a1ced08e-5f3f-4d84-a39f-507734086ae2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ziprasidone hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Wockhardt Limited
Application: ANDA090348
Marketing category: ANDA
Marketing start: 2012-09-01
Marketing end: 0000-00-00
Substance: ZIPRASIDONE HYDROCHLORIDE
Active strength: 40 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55648-992		I	Inactivated by FDA	2026-10-15
excluded package	package	55648-992	55648-992-01	I	Inactivated by FDA	2026-10-15
excluded package	package	55648-992	55648-992-02	I	Inactivated by FDA	2026-10-15
excluded package	package	55648-992	55648-992-03	I	Inactivated by FDA	2026-10-15
excluded package	package	55648-992	55648-992-04	I	Inactivated by FDA	2026-10-15
excluded package	package	55648-992	55648-992-06	I	Inactivated by FDA	2026-10-15

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 3 · 126 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	55648-992-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-992-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-992-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-992-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-992-01	`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	55648-992-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-992-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-992-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-992-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-992-01	`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	55648-992-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-992-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-992-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-992-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-992-01	`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	55648-992-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-992-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-992-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-992-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-992-01	`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	55648-992-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-992-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-992-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-992-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-992-01	`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	55648-992-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-992-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-992-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-992-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-992-01	`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	55648-992-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-992-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-992-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-992-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-992-01	`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	55648-992-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-992-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-992-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-992-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-992-01	`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	55648-992-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55648-992-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55648-992-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55648-992-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55648-992-01	`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	55648-992-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55648-992-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55648-992-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55648-992-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55648-992-01	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 176 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
2026-10-15 13:18:30	2026-09	A090348-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-09-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090348-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-09-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090348-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-09-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090348-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-09-05	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090348-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090348-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090348-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090348-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-09-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090348-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090348-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090348-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090348-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-09-05	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 5 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A090348-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090348-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090348-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090348-004	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090348-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090348-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090348-003	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090348-004	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090348-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090348-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090348-003	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090348-004	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090348-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090348-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090348-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090348-004	AB	1	`a50c72e98297…`

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, Related label table
NDC	Related label
55648-992-01	These highlights do not include all the information needed to use ziprasidone hydrochloride safely and effectively. See full prescribing information for ziprasidone hydrochloride. Ziprasidone Hydrochloride Capsules Initial U.S. Approval: 2001
55648-992-02	These highlights do not include all the information needed to use ziprasidone hydrochloride safely and effectively. See full prescribing information for ziprasidone hydrochloride. Ziprasidone Hydrochloride Capsules Initial U.S. Approval: 2001
55648-992-03	These highlights do not include all the information needed to use ziprasidone hydrochloride safely and effectively. See full prescribing information for ziprasidone hydrochloride. Ziprasidone Hydrochloride Capsules Initial U.S. Approval: 2001
55648-992-04	These highlights do not include all the information needed to use ziprasidone hydrochloride safely and effectively. See full prescribing information for ziprasidone hydrochloride. Ziprasidone Hydrochloride Capsules Initial U.S. Approval: 2001
55648-992-06	These highlights do not include all the information needed to use ziprasidone hydrochloride safely and effectively. See full prescribing information for ziprasidone hydrochloride. Ziprasidone Hydrochloride Capsules Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55648-992-01	Ziprasidone hydrochloride	30 in 1 BOTTLE	CAPSULE	30	1
55648-992-02	Ziprasidone hydrochloride	60 in 1 BOTTLE	CAPSULE	60	1
55648-992-03	Ziprasidone hydrochloride	100 in 1 BOTTLE	CAPSULE	100	1
55648-992-04	Ziprasidone hydrochloride	500 in 1 BOTTLE	CAPSULE	500	1
55648-992-06	Ziprasidone hydrochloride	8 in 1 BLISTER PACK	CAPSULE	8	1
55648-992-06	Ziprasidone hydrochloride	10 in 1 CARTON	CAPSULE	10	1

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55648-992	ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]	1	Legacy NDC, 6 package rows	20120906_81ca60c4-376b-43b7-b050-09e328fc403c.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 · 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
314286	ziprasidone HCl 20 MG Oral Capsule	PSN	81ca60c4-376b-43b7-b050-09e328fc403c	1
313776	ziprasidone HCl 40 MG Oral Capsule	PSN	81ca60c4-376b-43b7-b050-09e328fc403c	1
313777	ziprasidone HCl 60 MG Oral Capsule	PSN	81ca60c4-376b-43b7-b050-09e328fc403c	1
313778	ziprasidone HCl 80 MG Oral Capsule	PSN	81ca60c4-376b-43b7-b050-09e328fc403c	1
314286	ziprasidone 20 MG Oral Capsule	SCD	81ca60c4-376b-43b7-b050-09e328fc403c	1
313776	ziprasidone 40 MG Oral Capsule	SCD	81ca60c4-376b-43b7-b050-09e328fc403c	1
313777	ziprasidone 60 MG Oral Capsule	SCD	81ca60c4-376b-43b7-b050-09e328fc403c	1
313778	ziprasidone 80 MG Oral Capsule	SCD	81ca60c4-376b-43b7-b050-09e328fc403c	1
314286	ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral Capsule	SY	81ca60c4-376b-43b7-b050-09e328fc403c	1
313777	ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral Capsule	SY	81ca60c4-376b-43b7-b050-09e328fc403c	1
313776	ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral Capsule	SY	81ca60c4-376b-43b7-b050-09e328fc403c	1
313778	ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral Capsule	SY	81ca60c4-376b-43b7-b050-09e328fc403c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
55648-992-01	55648099201	30 in 1 BOTTLE	Historical
55648-992-02	55648099202	60 in 1 BOTTLE	Historical
55648-992-03	55648099203	100 in 1 BOTTLE	Historical
55648-992-04	55648099204	500 in 1 BOTTLE	Historical
55648-992-06	55648099206	8 in 1 BLISTER PACK	Historical