FDA.reportPublic FDA data

NDC 43598-061-11 - ziprasidone mesylate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
43598-061
Requested NDC
43598-061-11
Package NDCs from labels
43598-061-11, 43598-061-58
Manufacturer
Dr.Reddy's Laboratories, Inc. | Gland Pharma Limited
Effective date
2021-07-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ziprasidone mesylate - Dr.Reddy's Laboratories, Inc. | Gland Pharma LimitedDr.Reddy's Laboratories, Inc. | Gland Pharma Limited2021-07-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-061-11ziprasidone mesylate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,12
43598-061-58ziprasidone mesylate1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-061ZIPRASIDONE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR.REDDY'S LABORATORIES, INC. ]2Current NDC, Legacy NDC, 2 package rows20220831_6fd6fc45-20c4-e223-3532-ce37aa02b71c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-061-11EA - Each43598-06135ef85ad-4330-4b1c-9a31-cfa549440cd412022-05-04
43598-061-58EA - Each43598-0614b0ce51e-1c2b-40a0-92ef-31e0f33c511612022-05-04

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 ยท 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ziprasidone MesylateZIPRASIDONE MESYLATESTERISCIENCE SPECIALTIES PRIVATE LIMITED1ffd16c3-25ac-4839-9ea9-4efd32926b952025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351223
unii: 3X6SAX83JZ
ziprasidone mesylateZIPRASIDONE MESYLATENovadoz Pharmaceuticals LLC90b35a26-ab65-4c39-b97f-55c8c0e34b0b2025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351223
unii: 3X6SAX83JZ
Ziprasidone MesylateZIPRASIDONE MESYLATEFosun Pharma USA Inc.b28a4f3d-0aae-050d-e053-2995a90aa4a62025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211908
rxcui: 351223
unii: 3X6SAX83JZ
Ziprasidone MesylateZIPRASIDONE MESYLATEFosun Pharma USA Inc.90f55022-8d58-4bfb-9464-9bf11395ae172025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211908
rxcui: 351223
unii: 3X6SAX83JZ
ziprasidone mesylateZIPRASIDONE MESYLATEGland Pharma Limited77a10f48-e300-465f-81b5-54be38daa4b32025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211908
rxcui: 351223
unii: 3X6SAX83JZ
ZIPRASIDONE MESYLATEZIPRASIDONE MESYLATEHF Acquisition Co LLC, DBA HealthFirstc75971f8-9640-a6e8-e053-2995a90af6542024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211908
rxcui: 351223
unii: 3X6SAX83JZ
ziprasidone mesylateZIPRASIDONE MESYLATEDr.Reddy's Laboratories, Inc.3cb79985-1207-602e-2dda-a118133b4c602021-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211908
rxcui: 351223
unii: 3X6SAX83JZ
ziprasidone mesylateZIPRASIDONE MESYLATEDr.Reddy's Laboratories, Inc.6fd6fc45-20c4-e223-3532-ce37aa02b71c2021-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211908
ndc (package): 43598-061-11
ndc (package): 43598-061-58
ndc (product): 43598-061
ndc11 (package): 43598006111
rxcui: 351223
spl id: b94a787b-0592-ac3d-b887-c706d571f6e8
spl set id: 6fd6fc45-20c4-e223-3532-ce37aa02b71c
unii: 3X6SAX83JZ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.