ziprasidone mesylate

Product NDC: 43598-061
11-digit product format: 435980061
Labeler code: 43598
Product ID: 43598-061_b94a787b-0592-ac3d-b887-c706d571f6e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ziprasidone mesylate
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAMUSCULAR
Labeler: Dr.Reddy's Laboratories, Inc.
Application: ANDA211908
Marketing category: ANDA
Marketing start: 2022-03-22
Substance: ZIPRASIDONE MESYLATE
Active strength: 20 mg/mL
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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211908-001	ZIPRASIDONE MESYLATE	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP		2019-12-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211908-001	AP

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.

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	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR	AP	2019-12-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR	AP	2019-12-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR	AP	2019-12-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR	AP	2019-12-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR	AP	2019-12-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR	AP	2019-12-26	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211908-001	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	2019-12-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211908-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211908-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211908-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211908-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211908-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211908-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211908-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211908-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211908-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211908-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211908-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211908-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211908-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211908-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211908-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211908-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211908-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211908-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211908-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211908-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211908-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211908-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211908-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211908-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211908-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211908-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211908-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211908-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211908-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211908-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211908-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211908-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211908-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211908-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211908-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211908-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211908-001	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: ziprasidone mesylate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZIPRASIDONE MESYLATE	20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3X6SAX83JZ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
351223	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
6fd6fc45-20c4-e223-3532-ce37aa02b71c	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
43598-061-11	ziprasidone mesylate	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	1		2
43598-061-58	ziprasidone mesylate	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-061-11	EA - Each	43598-061	35ef85ad-4330-4b1c-9a31-cfa549440cd4	1	2022-05-04
43598-061-58	EA - Each	43598-061	4b0ce51e-1c2b-40a0-92ef-31e0f33c5116	1	2022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-061	ZIPRASIDONE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR.REDDY'S LABORATORIES, INC. ]	2	Current NDC, Legacy NDC, 2 package rows	20220831_6fd6fc45-20c4-e223-3532-ce37aa02b71c.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ziprasidone Mesylate	ZIPRASIDONE MESYLATE	Fosun Pharma USA Inc.	b28a4f3d-0aae-050d-e053-2995a90aa4a6	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211908 application number: ANDA211908
Ziprasidone Mesylate	ZIPRASIDONE MESYLATE	Fosun Pharma USA Inc.	90f55022-8d58-4bfb-9464-9bf11395ae17	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211908 application number: ANDA211908
ziprasidone mesylate	ZIPRASIDONE MESYLATE	Gland Pharma Limited	77a10f48-e300-465f-81b5-54be38daa4b3	2025-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211908 application number: ANDA211908
ZIPRASIDONE MESYLATE	ZIPRASIDONE MESYLATE	HF Acquisition Co LLC, DBA HealthFirst	c75971f8-9640-a6e8-e053-2995a90af654	2024-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211908 application number: ANDA211908
ziprasidone mesylate	ZIPRASIDONE MESYLATE	Dr.Reddy's Laboratories, Inc.	3cb79985-1207-602e-2dda-a118133b4c60	2021-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211908 application number: ANDA211908
ziprasidone mesylate	ZIPRASIDONE MESYLATE	Dr.Reddy's Laboratories, Inc.	6fd6fc45-20c4-e223-3532-ce37aa02b71c	2021-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211908 application number: ANDA211908 ndc (product): 43598-061

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3X6SAX83JZ	ZIPRASIDONE MESYLATE	199191-69-0	ZIPRASIDONE MESYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
351223	ziprasidone 20 MG Injection	PSN	6fd6fc45-20c4-e223-3532-ce37aa02b71c	2
351223	ziprasidone 20 MG Injection	SCD	6fd6fc45-20c4-e223-3532-ce37aa02b71c	2
351223	ziprasidone (as ziprasidone mesylate) 20 MG Injection	SY	6fd6fc45-20c4-e223-3532-ce37aa02b71c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-061-11	43598006111	1 mL in 1 VIAL, SINGLE-DOSE	1 ml					Historical
43598-061-58	43598006158	1 VIAL, SINGLE-DOSE in 1 CARTON (43598-061-58) / 1 mL in 1 VIAL, SINGLE-DOSE (43598-061-11)		2022-03-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ziprasidone mesylate	Dr.Reddy's Laboratories, Inc. \| Gland Pharma Limited	2021-07-30	HUMAN PRESCRIPTION DRUG LABEL	2