FDA.reportPublic FDA data

Ziprasidone Mesylate

Product NDC
82449-004
11-digit product format
824490004
Labeler code
82449
Product ID
82449-004_3eebc107-3b95-1b1e-e063-6394a90afed2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone mesylate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
STERISCIENCE SPECIALTIES PRIVATE LIMITED
Application
ANDA217595
Marketing category
ANDA
Marketing start
2025-12-19
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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217595-001ZIPRASIDONE MESYLATEZIPRASIDONE MESYLATEEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAP2025-09-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217595-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A217595-001ZIPRASIDONE MESYLATEEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAP2025-09-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217595-001ZIPRASIDONE MESYLATEEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAP2025-09-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217595-001ZIPRASIDONE MESYLATEEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAP2025-09-0331067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217595-001ZIPRASIDONE MESYLATEEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAP2025-09-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217595-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217595-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217595-001AP131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217595-001AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Ziprasidone Mesylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZIPRASIDONE MESYLATE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3X6SAX83JZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
351223Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1ffd16c3-25ac-4839-9ea9-4efd32926b95Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
defe29d6-6a09-c3aa-4400-b1130380ccc3Product name520231206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82449-004-01Ziprasidone Mesylate1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11
82449-004-01Ziprasidone Mesylate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,11
82449-004-02Ziprasidone Mesylate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,11
82449-004-02Ziprasidone Mesylate10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101

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 · 1 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
application applno (ANDA): 217595
application number: ANDA217595
ndc (product): 82449-004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351223ziprasidone 20 MG InjectionPSN1ffd16c3-25ac-4839-9ea9-4efd32926b951
351223ziprasidone 20 MG InjectionSCD1ffd16c3-25ac-4839-9ea9-4efd32926b951
351223ziprasidone (as ziprasidone mesylate) 20 MG InjectionSY1ffd16c3-25ac-4839-9ea9-4efd32926b951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82449-004-01824490004011 VIAL, SINGLE-DOSE in 1 CARTON (82449-004-01) / 1 mL in 1 VIAL, SINGLE-DOSE2025-12-19NoNoCurrent
82449-004-028244900040210 VIAL, SINGLE-DOSE in 1 CARTON (82449-004-02) / 1 mL in 1 VIAL, SINGLE-DOSE2025-12-19NoNoCurrent