ziprasidone

Product NDC: 70518-4475
Requested package NDC: 70518-4475-3
11-digit product format: 705184475
Labeler code: 70518
Product ID: 70518-4475_5268eb27-7ee8-e1de-e063-6294a90a96ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ziprasidone
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA077565
Marketing category: ANDA
Marketing start: 2025-09-11
Substance: ZIPRASIDONE HYDROCHLORIDE
Active strength: 60 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
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 · 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	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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077565-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-03-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077565-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-03-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077565-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-03-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077565-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-03-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077565-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-03-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077565-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-03-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077565-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-03-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077565-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-03-02	`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	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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077565-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077565-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077565-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077565-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077565-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077565-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077565-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077565-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: ziprasidone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZIPRASIDONE HYDROCHLORIDE	60 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
313777	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
48b54613-9b5f-4fcb-ba1f-22085ee0d8d1	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-4475-0	ziprasidone	30 in 1 BLISTER PACK	CAPSULE	30	3
70518-4475-1	ziprasidone	30 in 1 BOX	CAPSULE	30	3
70518-4475-2	ziprasidone	1 in 1 POUCH	CAPSULE	1	3

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	2026-07-29	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 ndc (package): 70518-4475-3 ndc (product): 70518-4475 ndc11 (package): 70518447503
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	ZIPRASIDONE	Major Pharmaceuticals	ca55c149-5b9a-4144-b586-37cb5e84dc4e	2025-08-26	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
6UKA5VEJ6X	ZIPRASIDONE	146939-27-7	ziprasidone

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313777	ziprasidone HCl 60 MG Oral Capsule	PSN	48b54613-9b5f-4fcb-ba1f-22085ee0d8d1	3
313777	ziprasidone 60 MG Oral Capsule	SCD	48b54613-9b5f-4fcb-ba1f-22085ee0d8d1	3
313777	ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral Capsule	SY	48b54613-9b5f-4fcb-ba1f-22085ee0d8d1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Status
70518-4475-3	70518447503	50 POUCH in 1 BOX (70518-4475-3) / 1 CAPSULE in 1 POUCH (70518-4475-2)	50 pouch	2026-07-08	0	Current