Ziprasidone Hydrochloride

Product NDC: 68084-104
11-digit product format: 680840104
Labeler code: 68084
Product ID: 68084-104_3d34b9a4-f85e-f66c-e063-6394a90a0518
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ziprasidone HCl
Dosage form: CAPSULE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA077561
Marketing category: ANDA
Marketing start: 2014-12-17
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
A077561-001	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-03-02
A077561-002	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-03-02
A077561-003	ZIPRASIDONE HYDROCHLORIDE	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-03-02
A077561-004	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
A077561-001	AB
A077561-002	AB
A077561-003	AB
A077561-004	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	A077561-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077561-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077561-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077561-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-03-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077561-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077561-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077561-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077561-004	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	A077561-001	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	A077561-002	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	A077561-003	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	A077561-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-03-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077561-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077561-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077561-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077561-004	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	A077561-001	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	A077561-002	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	A077561-003	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	A077561-004	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	A077561-001	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	A077561-002	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	A077561-003	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	A077561-004	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	A077561-001	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	A077561-002	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	A077561-003	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	A077561-004	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	A077561-001	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	A077561-002	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	A077561-003	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	A077561-004	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	A077561-001	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	A077561-002	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	A077561-003	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	A077561-004	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	A077561-001	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	A077561-002	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	A077561-003	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	A077561-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-03-02	`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	A077561-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077561-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077561-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077561-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077561-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077561-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077561-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077561-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077561-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077561-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077561-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077561-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077561-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077561-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077561-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077561-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077561-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077561-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077561-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077561-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077561-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077561-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077561-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077561-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077561-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077561-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077561-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077561-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077561-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077561-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077561-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077561-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077561-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077561-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077561-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077561-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077561-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077561-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077561-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077561-004	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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313776	Internal RxNorm lookup
313777	Internal RxNorm lookup
313778	Internal RxNorm lookup
314286	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
ba039e48-7bde-4fc5-bd39-8c9dfa98fada	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	Strength	SPL version
68084-104-09	Ziprasidone Hydrochloride	80 in 1 BOX, UNIT-DOSE	CAPSULE	80		10
68084-104-11	Ziprasidone Hydrochloride	1 in 1 BLISTER PACK	CAPSULE	1		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-104-09	EA - Each	68084-104	16481013-c3e6-4ac9-a0ff-a0f84278d0d8	1	2015-01-05
68084-104-11	EA - Each	68084-104	183dfe18-9f4e-4cff-ac6a-48c585face17	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZIPRASIDONE HYDROCHLORIDE	ACTIVE INGREDIENT	216X081ORU	ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]	2
ZIPRASIDONE	ACTIVE MOIETY	6UKA5VEJ6X	ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-104	ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HCL) CAPSULE [AMERICAN HEALTH PACKAGING]	9	Current NDC, Legacy NDC, 2 package rows	20241004_ba039e48-7bde-4fc5-bd39-8c9dfa98fada.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 · 7 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	Exact identifier application applno (ANDA): 077561 application number: ANDA077561
ziprasidone hydrochloride	ZIPRASIDONE HCL	Apotex Corp.	ccfd5ba2-7271-f3dd-4c98-7418c1a4b54a	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077561 application number: ANDA077561
ziprasidone hydrochloride	ZIPRASIDONE HCL	Golden State Medical Supply, Inc.	b1f52226-4fb4-48bf-8bfd-0c9df6ca02fa	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077561 application number: ANDA077561
ziprasidone hydrochloride	ZIPRASIDONE HCL	AvPAK	c227a618-1274-2b4d-e053-2a95a90a74fb	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077561 application number: ANDA077561
Ziprasidone Hydrochloride	ZIPRASIDONE HCL	American Health Packaging	ba039e48-7bde-4fc5-bd39-8c9dfa98fada	2025-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077561 application number: ANDA077561 ndc (product): 68084-104
ziprasidone hydrochloride	ZIPRASIDONE HCL	Proficient Rx LP	f60b6892-a437-450d-906a-978272148feb	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077561 application number: ANDA077561
ziprasidone hydrochloride	ZIPRASIDONE HCL	Proficient Rx LP	80c13492-3873-48ba-882f-58e02dc7237d	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077561 application number: ANDA077561

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
314286	ziprasidone HCl 20 MG Oral Capsule	PSN	ba039e48-7bde-4fc5-bd39-8c9dfa98fada	10
313776	ziprasidone HCl 40 MG Oral Capsule	PSN	ba039e48-7bde-4fc5-bd39-8c9dfa98fada	10
313777	ziprasidone HCl 60 MG Oral Capsule	PSN	ba039e48-7bde-4fc5-bd39-8c9dfa98fada	10
313778	ziprasidone HCl 80 MG Oral Capsule	PSN	ba039e48-7bde-4fc5-bd39-8c9dfa98fada	10
314286	ziprasidone 20 MG Oral Capsule	SCD	ba039e48-7bde-4fc5-bd39-8c9dfa98fada	10
313776	ziprasidone 40 MG Oral Capsule	SCD	ba039e48-7bde-4fc5-bd39-8c9dfa98fada	10
313777	ziprasidone 60 MG Oral Capsule	SCD	ba039e48-7bde-4fc5-bd39-8c9dfa98fada	10
313778	ziprasidone 80 MG Oral Capsule	SCD	ba039e48-7bde-4fc5-bd39-8c9dfa98fada	10
314286	ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral Capsule	SY	ba039e48-7bde-4fc5-bd39-8c9dfa98fada	10
313777	ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral Capsule	SY	ba039e48-7bde-4fc5-bd39-8c9dfa98fada	10
313776	ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral Capsule	SY	ba039e48-7bde-4fc5-bd39-8c9dfa98fada	10
313778	ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral Capsule	SY	ba039e48-7bde-4fc5-bd39-8c9dfa98fada	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-104-09	68084010409	80 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-104-09) / 1 CAPSULE in 1 BLISTER PACK (68084-104-11)	80 blister pack	2014-12-17	0000-00-00	No	No	Current
68084-104-11	68084010411	1 in 1 BLISTER PACK						Historical