Ziprasidone

Product NDC: 0904-6270
11-digit product format: 009046270
Labeler code: 0904
Product ID: 0904-6270_11aa05a7-d934-4932-990a-da13164d3825
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ziprasidone
Dosage form: CAPSULE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA077565
Marketing category: ANDA
Marketing start: 2012-03-15
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
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 · 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	A077565-001	ZIPRASIDONE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB	2012-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077565-002	ZIPRASIDONE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2012-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077565-003	ZIPRASIDONE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL	AB	2012-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077565-004	ZIPRASIDONE HYDROCHLORIDE	EQ 80MG BASE	CAPSULE / ORAL	AB	2012-03-02	`caaa826d4ba7…`
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…`

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	A077565-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077565-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077565-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077565-004	AB	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

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

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
ca55c149-5b9a-4144-b586-37cb5e84dc4e	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
0904-6270-08	Ziprasidone	40 in 1 CARTON	CAPSULE	40	10
0904-6270-08	Ziprasidone	1 in 1 BLISTER PACK	CAPSULE	1	10
0904-6270-45	Ziprasidone	80 in 1 CARTON	CAPSULE	80	10
0904-6270-45	Ziprasidone	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
0904-6270-08	EA - Each	0904-6270	a61e1b4e-3945-4536-9737-5a8cfbd29dfa	1	2012-07-24
0904-6270-45	EA - Each	0904-6270	c35842e4-503e-475e-a412-ebe1ba041613	1	2019-04-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZIPRASIDONE HYDROCHLORIDE	ACTIVE INGREDIENT	216X081ORU	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
ZIPRASIDONE	ACTIVE MOIETY	6UKA5VEJ6X	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
1-PROPOXY-2-PROPANOL	INACTIVE INGREDIENT	152BY1743W	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
PHENOXYISOPROPANOL	INACTIVE INGREDIENT	87CZY0NY1A	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6270	ZIPRASIDONE CAPSULE [MAJOR PHARMACEUTICALS]	9	Current NDC, Legacy NDC, 4 package rows	20241228_ca55c149-5b9a-4144-b586-37cb5e84dc4e.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 · 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	2026-08-03	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
Ziprasidone	ZIPRASIDONE	Major Pharmaceuticals	ca55c149-5b9a-4144-b586-37cb5e84dc4e	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077565 application number: ANDA077565 ndc (product): 0904-6270
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 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
314286	ziprasidone HCl 20 MG Oral Capsule	PSN	ca55c149-5b9a-4144-b586-37cb5e84dc4e	10
313776	ziprasidone HCl 40 MG Oral Capsule	PSN	ca55c149-5b9a-4144-b586-37cb5e84dc4e	10
313777	ziprasidone HCl 60 MG Oral Capsule	PSN	ca55c149-5b9a-4144-b586-37cb5e84dc4e	10
313778	ziprasidone HCl 80 MG Oral Capsule	PSN	ca55c149-5b9a-4144-b586-37cb5e84dc4e	10
314286	ziprasidone 20 MG Oral Capsule	SCD	ca55c149-5b9a-4144-b586-37cb5e84dc4e	10
313776	ziprasidone 40 MG Oral Capsule	SCD	ca55c149-5b9a-4144-b586-37cb5e84dc4e	10
313777	ziprasidone 60 MG Oral Capsule	SCD	ca55c149-5b9a-4144-b586-37cb5e84dc4e	10
313778	ziprasidone 80 MG Oral Capsule	SCD	ca55c149-5b9a-4144-b586-37cb5e84dc4e	10
314286	ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral Capsule	SY	ca55c149-5b9a-4144-b586-37cb5e84dc4e	10
313777	ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral Capsule	SY	ca55c149-5b9a-4144-b586-37cb5e84dc4e	10
313776	ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral Capsule	SY	ca55c149-5b9a-4144-b586-37cb5e84dc4e	10
313778	ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral Capsule	SY	ca55c149-5b9a-4144-b586-37cb5e84dc4e	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6270-08	00904627008	40 BLISTER PACK in 1 CARTON (0904-6270-08) / 1 CAPSULE in 1 BLISTER PACK	40 blister pack	2012-03-15	0000-00-00	No	No	Current
0904-6270-45	00904627045	80 BLISTER PACK in 1 CARTON (0904-6270-45) / 1 CAPSULE in 1 BLISTER PACK	80 blister pack	2012-03-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ziprasidone	Major Pharmaceuticals	2026-06-09	HUMAN PRESCRIPTION DRUG LABEL	11
Ziprasidone Hydrochloride	REMEDYREPACK INC.	2016-08-31	HUMAN PRESCRIPTION DRUG LABEL	1