Application 077562

Type: ANDA
Sponsor: SANDOZ INC

Application Products#

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

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
A077562-001	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-01
A077562-002	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-01
A077562-003	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-06-01
A077562-004	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-06-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077562-001	AB
A077562-002	AB
A077562-003	AB
A077562-004	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	A077562-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077562-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077562-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077562-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-06-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077562-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077562-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077562-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077562-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077562-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077562-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077562-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077562-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077562-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077562-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077562-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077562-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077562-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077562-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077562-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077562-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077562-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077562-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077562-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077562-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077562-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077562-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077562-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077562-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077562-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077562-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077562-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077562-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077562-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077562-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077562-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077562-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077562-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-06-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077562-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-06-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077562-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-06-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077562-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-06-01	`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	A077562-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077562-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077562-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077562-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077562-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077562-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077562-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077562-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077562-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077562-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077562-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077562-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077562-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077562-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077562-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077562-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077562-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077562-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077562-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077562-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077562-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077562-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077562-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077562-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077562-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077562-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077562-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077562-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077562-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077562-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077562-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077562-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077562-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077562-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077562-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077562-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077562-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077562-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077562-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077562-004	AB	1	`d8e5a09893c0…`

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ziprasidone hydrochloride	ZIPRASIDONE HCL	Bryant Ranch Prepack	947881af-08e6-47eb-87e3-24cc162c12bc	2026-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ziprasidone hydrochloride
ziprasidone hydrochloride	ZIPRASIDONE HCL	Apotex Corp.	ccfd5ba2-7271-f3dd-4c98-7418c1a4b54a	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ziprasidone hydrochloride
ziprasidone hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	5d576819-cd14-4a61-8a2f-6b90d8eac07e	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ziprasidone hydrochloride 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 brand name: Ziprasidone Hydrochloride 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 brand name: Ziprasidone Hydrochloride 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 brand name: Ziprasidone Hydrochloride generic name: ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride	ZIPRASIDONE HCL	Golden State Medical Supply, Inc.	b1f52226-4fb4-48bf-8bfd-0c9df6ca02fa	2026-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ziprasidone hydrochloride
ziprasidone hydrochloride	ZIPRASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	56370be6-42a2-4962-acdc-22b7c6e0e7fe	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ziprasidone hydrochloride 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 brand name: ziprasidone hydrochloride 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 brand name: Ziprasidone Hydrochloride generic name: ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride	ZIPRASIDONE HCL	AvPAK	c227a618-1274-2b4d-e053-2a95a90a74fb	2026-01-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ziprasidone hydrochloride
Ziprasidone Hydrochloride	ZIPRASIDONE HCL	American Health Packaging	ba039e48-7bde-4fc5-bd39-8c9dfa98fada	2025-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand 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 brand name: Ziprasidone Hydrochloride 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 brand name: Ziprasidone Hydrochloride 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 brand name: ziprasidone hydrochloride generic name: ZIPRASIDONE HYDROCHLORIDE
Geodon	ZIPRASIDONE HYDROCHLORIDE	ROERIG	8326928a-2cb6-4f7f-9712-03a425a14c37	2025-01-13	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 brand name: Ziprasidone Hydrochloride 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 brand name: Ziprasidone Hydrochloride 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 brand name: Ziprasidone Hydrochloride 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 brand name: Ziprasidone Hydrochloride generic name: ZIPRASIDONE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-2164	ziprasidone hydrochloride	ziprasidone hydrochloride	Sandoz Inc	ANDA	Current
0781-2164	ziprasidone hydrochloride	ziprasidone hydrochloride	Sandoz Inc	ANDA	Current
0781-2164	ziprasidone hydrochloride	ziprasidone hydrochloride	Sandoz Inc	ANDA	Current
0781-2164	ziprasidone hydrochloride	ziprasidone hydrochloride	Sandoz Inc	ANDA	Current
0781-2164	ziprasidone hydrochloride	ziprasidone hydrochloride	Sandoz Inc	ANDA	Current
0781-2166	ziprasidone hydrochloride	ziprasidone hydrochloride	Sandoz Inc	ANDA	Current
0781-2166	ziprasidone hydrochloride	ziprasidone hydrochloride	Sandoz Inc	ANDA	Current
0781-2166	ziprasidone hydrochloride	ziprasidone hydrochloride	Sandoz Inc	ANDA	Current
0781-2166	ziprasidone hydrochloride	ziprasidone hydrochloride	Sandoz Inc	ANDA	Current
0781-2166	ziprasidone hydrochloride	ziprasidone hydrochloride	Sandoz Inc	ANDA	Current
0781-2167	ziprasidone hydrochloride	ziprasidone hydrochloride	Sandoz Inc	ANDA	Current
0781-2167	ziprasidone hydrochloride	ziprasidone hydrochloride	Sandoz Inc	ANDA	Current
0781-2167	ziprasidone hydrochloride	ziprasidone hydrochloride	Sandoz Inc	ANDA	Current
0781-2167	ziprasidone hydrochloride	ziprasidone hydrochloride	Sandoz Inc	ANDA	Current
0781-2167	ziprasidone hydrochloride	ziprasidone hydrochloride	Sandoz Inc	ANDA	Current
0781-2168	ziprasidone hydrochloride	ziprasidone hydrochloride	Sandoz Inc	ANDA	Current
0781-2168	ziprasidone hydrochloride	ziprasidone hydrochloride	Sandoz Inc	ANDA	Current
0781-2168	ziprasidone hydrochloride	ziprasidone hydrochloride	Sandoz Inc	ANDA	Current
0781-2168	ziprasidone hydrochloride	ziprasidone hydrochloride	Sandoz Inc	ANDA	Current
0781-2168	ziprasidone hydrochloride	ziprasidone hydrochloride	Sandoz Inc	ANDA	Current
50090-3823	ziprasidone hydrochloride	ziprasidone hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3823	ziprasidone hydrochloride	ziprasidone hydrochloride	A-S Medication Solutions	ANDA	Current
63187-168	ziprasidone hydrochloride	ziprasidone hydrochloride	Proficient Rx LP	ANDA	Current
63187-168	ziprasidone hydrochloride	ziprasidone hydrochloride	Proficient Rx LP	ANDA	Current
64725-2164	ziprasidone hydrochloride	ziprasidone hydrochloride	TYA Pharmaceuticals	ANDA	Current
64725-2168	ziprasidone hydrochloride	ziprasidone hydrochloride	TYA Pharmaceuticals	ANDA	Current
70518-1586	ziprasidone hydrochloride	ziprasidone hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1586	ziprasidone hydrochloride	ziprasidone hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1586	ziprasidone hydrochloride	ziprasidone hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1586	ziprasidone hydrochloride	ziprasidone hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1586	ziprasidone hydrochloride	ziprasidone hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2366	ziprasidone hydrochloride	ziprasidone hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2366	ziprasidone hydrochloride	ziprasidone hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2366	ziprasidone hydrochloride	ziprasidone hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2367	ziprasidone hydrochloride	ziprasidone hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2367	ziprasidone hydrochloride	ziprasidone hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2367	ziprasidone hydrochloride	ziprasidone hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-0263	ziprasidone hydrochloride	ziprasidone hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0263	ziprasidone hydrochloride	ziprasidone hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0263	ziprasidone hydrochloride	ziprasidone hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0263	ziprasidone hydrochloride	ziprasidone hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9061	ORIG	2011-04-21
44356	ORIG	2008-11-13