Ziprasidone Hydrochloride

Product NDC: 63629-3331
11-digit product format: 636293331
Labeler code: 63629
Product ID: 63629-3331_3e3f03f9-e3d1-493d-b3d7-1f8215d6a9ee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ziprasidone Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA204375
Marketing category: ANDA
Marketing start: 2017-02-18
Substance: ZIPRASIDONE HYDROCHLORIDE
Active strength: 40 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A204375-001	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2017-02-17
A204375-002	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-02-17
A204375-003	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-02-17
A204375-004	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-02-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204375-001	AB
A204375-002	AB
A204375-003	AB
A204375-004	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 · 168 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
2026-08-18 06:07:40	2026-07	A204375-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2017-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204375-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204375-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204375-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-02-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204375-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2017-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204375-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204375-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204375-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204375-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2017-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204375-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204375-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204375-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204375-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2017-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204375-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204375-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204375-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204375-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2017-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204375-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204375-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204375-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204375-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2017-02-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204375-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-02-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204375-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-02-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204375-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204375-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2017-02-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204375-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-02-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204375-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-02-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204375-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204375-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2017-02-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204375-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-02-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204375-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-02-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204375-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204375-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2017-02-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204375-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-02-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204375-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-02-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204375-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204375-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2017-02-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204375-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2017-02-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204375-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2017-02-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204375-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2017-02-17	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204375-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204375-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204375-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204375-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204375-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204375-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204375-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204375-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204375-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204375-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204375-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204375-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204375-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204375-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204375-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204375-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204375-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204375-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204375-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204375-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204375-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204375-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204375-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204375-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204375-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204375-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204375-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204375-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204375-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204375-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204375-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204375-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204375-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204375-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204375-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204375-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204375-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204375-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204375-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204375-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ziprasidone Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZIPRASIDONE HYDROCHLORIDE	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
216X081ORU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313776	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fa70291d-8455-40d6-9b73-bf91880f9979	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-3331-1	Ziprasidone Hydrochloride	60 in 1 BOTTLE	CAPSULE	60	104
63629-3331-2	Ziprasidone Hydrochloride	28 in 1 BOTTLE	CAPSULE	28	104
63629-3331-3	Ziprasidone Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	104
63629-3331-4	Ziprasidone Hydrochloride	90 in 1 BOTTLE	CAPSULE	90	104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-3331	ZIPRASIDONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	104	Current NDC, Legacy NDC, 4 package rows	20231026_fa70291d-8455-40d6-9b73-bf91880f9979.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	c9f8f635-cf3f-4c42-8bd1-45bbe19bf97e	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204375 application number: ANDA204375
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	a66a0b25-673c-4a3d-b923-5f65a02b8ff0	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204375 application number: ANDA204375
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	4e7e2d5d-8ea8-4c25-a500-f4794542fda2	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204375 application number: ANDA204375
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	7c683604-b827-434d-aff3-ee2ed0565cd7	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204375 application number: ANDA204375
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	A-S Medication Solutions	c3797145-cead-4fc4-9711-8b8623bb09f4	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204375 application number: ANDA204375
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	550aca3a-5051-432e-9a3f-a2e53cbd603d	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204375 application number: ANDA204375
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	798631b6-b9d9-44de-9a1a-ae2cee86d531	2023-11-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204375 application number: ANDA204375
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	fa70291d-8455-40d6-9b73-bf91880f9979	2023-10-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204375 application number: ANDA204375 ndc (product): 63629-3331
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Macleods Pharmaceuticals Limited	3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af0	2023-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204375 application number: ANDA204375

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
313776	ziprasidone HCl 40 MG Oral Capsule	PSN	fa70291d-8455-40d6-9b73-bf91880f9979	104
313776	ziprasidone 40 MG Oral Capsule	SCD	fa70291d-8455-40d6-9b73-bf91880f9979	104
313776	ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral Capsule	SY	fa70291d-8455-40d6-9b73-bf91880f9979	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-3331-1	63629333101	60 CAPSULE in 1 BOTTLE (63629-3331-1)	60 capsule	2022-03-08	0000-00-00	No	No	Current
63629-3331-2	63629333102	28 CAPSULE in 1 BOTTLE (63629-3331-2)	28 capsule	2022-03-08	0000-00-00	No	No	Current
63629-3331-3	63629333103	30 CAPSULE in 1 BOTTLE (63629-3331-3)	30 capsule	2021-05-14	0000-00-00	No	No	Current
63629-3331-4	63629333104	90 CAPSULE in 1 BOTTLE (63629-3331-4)	90 capsule	2022-01-20	0000-00-00	No	No	Current