ziprasidone hydrochloride

Product NDC: 0781-2166
11-digit product format: 007812166
Labeler code: 0781
Product ID: 0781-2166_7df70d10-a688-4718-9364-ac4915dec366
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ziprasidone hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA077562
Marketing category: ANDA
Marketing start: 2013-02-13
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: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0781-2166		D	Discontinued by firm		2026-08-17
excluded package	package	0781-2166	0781-2166-60	D	Discontinued by firm		2026-08-17

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 1 · 4 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	0781-2166-60	`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	0781-2166-60	`f5e01cc5f278…`	`a2eaf40c39c3…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-2166-60	EA - Each	0781-2166	fcbe817c-2173-4a5b-9428-e95563a33406	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZIPRASIDONE HYDROCHLORIDE	ACTIVE INGREDIENT	216X081ORU	ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]	8
ZIPRASIDONE	ACTIVE MOIETY	6UKA5VEJ6X	ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]	8
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]	8
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]	8
CALCIUM SILICATE	INACTIVE INGREDIENT	S4255P4G5M	ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]	8
CARBOXYMETHYLCELLULOSE	INACTIVE INGREDIENT	05JZI7B19X	ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]	8
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]	8
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]	8
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]	8
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]	8
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]	8
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]	8
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-2166	ZIPRASIDONE HYDROCHLORIDE CAPSULE [SANDOZ INC]	16	Legacy NDC	20250424_f3e54e15-945c-4e1e-b992-d01e6872d606.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
216X081ORU	ZIPRASIDONE HYDROCHLORIDE	138982-67-9	ZIPRASIDONE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-2166-60	00781216660	60 CAPSULE in 1 BOTTLE (0781-2166-60)	60 capsule	2013-02-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ziprasidone hydrochloride	REMEDYREPACK INC.	2025-07-02	HUMAN PRESCRIPTION DRUG LABEL	7
ziprasidone hydrochloride	Sandoz Inc	2025-02-18	HUMAN PRESCRIPTION DRUG LABEL	16