Application 020825

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GEODON	ZIPRASIDONE HYDROCHLORIDE	CAPSULE;ORAL	EQ 20MG BASE	Yes	Yes
002	GEODON	ZIPRASIDONE HYDROCHLORIDE	CAPSULE;ORAL	EQ 40MG BASE	Yes	No
003	GEODON	ZIPRASIDONE HYDROCHLORIDE	CAPSULE;ORAL	EQ 60MG BASE	Yes	No
004	GEODON	ZIPRASIDONE HYDROCHLORIDE	CAPSULE;ORAL	EQ 80MG BASE	Yes	No

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	RLD / RS	Approval date
N020825-001	GEODON	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	RLD, RS	2001-02-05
N020825-002	GEODON	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05
N020825-003	GEODON	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05
N020825-004	GEODON	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020825-001	AB
N020825-002	AB
N020825-003	AB
N020825-004	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020825-001	GEODON	EQ 20MG BASE	CAPSULE / ORAL	AB	RLD, RS	2001-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020825-002	GEODON	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020825-003	GEODON	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020825-004	GEODON	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020825-001	GEODON	EQ 20MG BASE	CAPSULE / ORAL	AB	RLD, RS	2001-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020825-002	GEODON	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020825-003	GEODON	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020825-004	GEODON	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020825-001	GEODON	EQ 20MG BASE	CAPSULE / ORAL	AB	RLD, RS	2001-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020825-002	GEODON	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020825-003	GEODON	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020825-004	GEODON	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020825-001	GEODON	EQ 20MG BASE	CAPSULE / ORAL	AB	RLD, RS	2001-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020825-002	GEODON	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020825-003	GEODON	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020825-004	GEODON	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020825-001	GEODON	EQ 20MG BASE	CAPSULE / ORAL	AB	RLD, RS	2001-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020825-002	GEODON	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020825-003	GEODON	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020825-004	GEODON	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020825-001	GEODON	EQ 20MG BASE	CAPSULE / ORAL	AB	RLD, RS	2001-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020825-002	GEODON	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020825-003	GEODON	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020825-004	GEODON	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020825-001	GEODON	EQ 20MG BASE	CAPSULE / ORAL	AB	RLD, RS	2001-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020825-002	GEODON	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020825-003	GEODON	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020825-004	GEODON	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020825-001	GEODON	EQ 20MG BASE	CAPSULE / ORAL	AB	RLD, RS	2001-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020825-002	GEODON	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020825-003	GEODON	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020825-004	GEODON	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020825-001	GEODON	EQ 20MG BASE	CAPSULE / ORAL	AB	RLD, RS	2001-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020825-002	GEODON	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020825-003	GEODON	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020825-004	GEODON	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020825-001	GEODON	EQ 20MG BASE	CAPSULE / ORAL	AB	RLD, RS	2001-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020825-002	GEODON	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020825-003	GEODON	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020825-004	GEODON	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD	2001-02-05	`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	N020825-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020825-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020825-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020825-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020825-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020825-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020825-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020825-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020825-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020825-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020825-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020825-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020825-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020825-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020825-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020825-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020825-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020825-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020825-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020825-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020825-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020825-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020825-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020825-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020825-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020825-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020825-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020825-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020825-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020825-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020825-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020825-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020825-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020825-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020825-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020825-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020825-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020825-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020825-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020825-004	AB	1	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020825-001	6150366	2019-05-27	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020825-002	6150366	2019-05-27	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020825-003	6150366	2019-05-27	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020825-004	6150366	2019-05-27	Drug product	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N020825-001	6150366	2019-05-27	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020825-002	6150366	2019-05-27	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020825-003	6150366	2019-05-27	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020825-004	6150366	2019-05-27	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020825-001	6150366	2019-05-27	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020825-002	6150366	2019-05-27	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020825-003	6150366	2019-05-27	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020825-004	6150366	2019-05-27	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020825-001	6150366	2019-05-27	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020825-002	6150366	2019-05-27	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020825-003	6150366	2019-05-27	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020825-004	6150366	2019-05-27	Drug product	`ea99ee380514…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 116 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020825-001	M-232	2025-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020825-002	M-232	2025-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020825-003	M-232	2025-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020825-004	M-232	2025-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020825-001	M-232	2025-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020825-002	M-232	2025-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020825-003	M-232	2025-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020825-004	M-232	2025-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020825-001	M-232	2025-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020825-002	M-232	2025-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020825-003	M-232	2025-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020825-004	M-232	2025-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020825-001	M-232	2025-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020825-002	M-232	2025-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020825-003	M-232	2025-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020825-004	M-232	2025-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020825-001	M-232	2025-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020825-002	M-232	2025-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020825-003	M-232	2025-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020825-004	M-232	2025-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020825-001	M-232	2025-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020825-002	M-232	2025-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020825-003	M-232	2025-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020825-004	M-232	2025-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020825-001	M-232	2025-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020825-002	M-232	2025-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020825-003	M-232	2025-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020825-004	M-232	2025-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020825-001	M-232	2025-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020825-002	M-232	2025-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020825-003	M-232	2025-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020825-004	M-232	2025-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020825-001	M-232	2025-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020825-002	M-232	2025-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020825-003	M-232	2025-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020825-004	M-232	2025-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020825-001	M-232	2025-01-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020825-002	M-232	2025-01-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020825-003	M-232	2025-01-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020825-004	M-232	2025-01-28	`79d66fd596c7…`

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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ziprasidone hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	5d576819-cd14-4a61-8a2f-6b90d8eac07e	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	c9f8f635-cf3f-4c42-8bd1-45bbe19bf97e	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	a66a0b25-673c-4a3d-b923-5f65a02b8ff0	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	4e7e2d5d-8ea8-4c25-a500-f4794542fda2	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride	ZIPRASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	56370be6-42a2-4962-acdc-22b7c6e0e7fe	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	14191e0d-8219-4f6e-b808-09c4804a8262	2026-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	7c683604-b827-434d-aff3-ee2ed0565cd7	2026-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Aurobindo Pharma Limited	cc5e1c44-79e9-45d3-b1e5-b003f550c508	2025-05-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	BluePoint Laboratories	c0eb7b4d-0264-4eed-8756-51bba3af82fb	2025-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride	ZIPRASIDONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fc9ffbc3-1f16-9265-e053-6294a90acfd2	2025-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	A-S Medication Solutions	c3797145-cead-4fc4-9711-8b8623bb09f4	2024-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	550aca3a-5051-432e-9a3f-a2e53cbd603d	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0fcebd61-25b2-d287-e063-6394a90a7b9a	2024-01-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	798631b6-b9d9-44de-9a1a-ae2cee86d531	2023-11-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	fa70291d-8455-40d6-9b73-bf91880f9979	2023-10-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	48e6e141-66d3-4eab-b0bf-dfd1d44b4832	2023-09-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Macleods Pharmaceuticals Limited	3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af0	2023-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 117 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59762-2001	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2001	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2001	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2001	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2001	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2001	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2002	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2002	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2002	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2002	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2002	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2002	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2002	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2002	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2003	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2003	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2003	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2003	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2003	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2003	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2003	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2003	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2004	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2004	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2004	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2004	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2004	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2004	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2004	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2004	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
69189-2003	Ziprasidone	ziprasidone hydrochloride	Avera McKennan Hospital	NDA AUTHORIZED GENERIC	Current
70518-1373	Geodon	ziprasidone hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-1373	Geodon	ziprasidone hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-2925	Ziprasidone	ziprasidone hydrochloride	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2925	Ziprasidone	ziprasidone hydrochloride	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-3376	Ziprasidone	ziprasidone	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-3376	Ziprasidone	ziprasidone	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81062	SUPPL	2025-02-06
80945	SUPPL	2025-02-05
70033	SUPPL	2022-02-01
70009	SUPPL	2022-01-31
67560	SUPPL	2021-05-20
67551	SUPPL	2021-05-19
66066	SUPPL	2021-02-02
65115	SUPPL	2020-11-02
61642	SUPPL	2020-01-24
61633	SUPPL	2020-01-24
56499	SUPPL	2018-11-16
56314	SUPPL	2018-11-06
47417	SUPPL	2017-03-02
47314	SUPPL	2017-02-24
35429	SUPPL	2015-09-14
25933	SUPPL	2015-08-24
35428	SUPPL	2014-12-11
3439	SUPPL	2014-12-11
35427	SUPPL	2013-12-19
25932	SUPPL	2013-12-19
3438	SUPPL	2013-08-16
13501	SUPPL	2013-08-15
35425	SUPPL	2013-07-05
3437	SUPPL	2013-07-05
25931	SUPPL	2013-03-05
35426	SUPPL	2013-03-04
20984	SUPPL	2012-10-12
44074	ORIG	2011-12-22
25930	SUPPL	2010-12-07
13500	SUPPL	2010-12-04
25928	SUPPL	2009-11-24
13499	SUPPL	2009-11-23
35424	SUPPL	2009-08-14
25929	SUPPL	2009-08-04
3436	SUPPL	2008-08-19
20983	SUPPL	2008-07-30
3435	SUPPL	2008-05-21
25927	SUPPL	2007-10-04
13498	SUPPL	2007-10-04
35423	SUPPL	2007-05-29
3434	SUPPL	2007-05-29
13497	SUPPL	2007-03-07
3433	SUPPL	2007-03-07
35422	SUPPL	2005-08-19
35421	SUPPL	2005-08-19
25926	SUPPL	2005-08-19
3432	SUPPL	2005-08-19
44466	SUPPL	2004-10-01
25925	SUPPL	2004-10-01
13496	SUPPL	2004-10-01
3431	SUPPL	2004-08-25
25924	SUPPL	2003-12-24
25923	SUPPL	2002-02-15
41723	ORIG	2001-02-05
25922	ORIG	2001-02-05
13495	ORIG	2001-02-05
53446	ORIG	1900-01-01
53445	ORIG	1900-01-01
53441	ORIG	1900-01-01
53440	ORIG	1900-01-01