ziprasidone hydrochloride

Product NDC
70518-2294
11-digit product format
705182294
Labeler code
70518
Product ID
70518-2294_52564e2f-97e6-89ba-e063-6394a90ab424
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077565
Marketing category
ANDA
Marketing start
2019-09-03
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-2294DDiscontinued by firm2026-08-17
excluded packagepackage70518-229470518-2294-0DDiscontinued by firm2026-08-17
excluded packagepackage70518-229470518-2294-1DDiscontinued by firm2026-08-17
excluded packagepackage70518-229470518-2294-3DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-229470518-2294-0DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077565-001ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-02
A077565-002ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-02
A077565-003ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-02
A077565-004ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A077565-001AB
A077565-002AB
A077565-003AB
A077565-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-02d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077565-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077565-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077565-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077565-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077565-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077565-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077565-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077565-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077565-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077565-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077565-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077565-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077565-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077565-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077565-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077565-004AB1d8e5a09893c0…

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
70518-2294-0ziprasidone hydrochloride30 in 1 BLISTER PACKCAPSULE3018
70518-2294-1ziprasidone hydrochloride30 in 1 BOXCAPSULE3018
70518-2294-2ziprasidone hydrochloride1 in 1 POUCHCAPSULE118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2294ZIPRASIDONE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 3 package rows20250311_7e7261d7-4902-4bb5-a268-6c358890f963.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ziprasidoneZIPRASIDONEREMEDYREPACK INC.6665279a-32ab-43ce-a258-039a6779a1a22026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidoneZIPRASIDONEREMEDYREPACK INC.3834670f-cc31-4ed9-87ec-b631339ae18a2026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidone hydrochlorideZIPRASIDONE HYDROCHLORIDEBryant Ranch Prepack5d576819-cd14-4a61-8a2f-6b90d8eac07e2026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidoneZIPRASIDONEREMEDYREPACK INC.48b54613-9b5f-4fcb-ba1f-22085ee0d8d12026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ZiprasidoneZIPRASIDONEMajor Pharmaceuticalsca55c149-5b9a-4144-b586-37cb5e84dc4e2026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidoneZIPRASIDONEDr. Reddy's Laboratories Limited396cb4a6-01a1-f73f-2a37-39df9067bf982026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidoneZIPRASIDONENorthStar Rx LLC0071a228-21cc-56a6-dcc9-a7a6ceea758c2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidone hydrochlorideZIPRASIDONE HYDROCHLORIDEREMEDYREPACK INC.56370be6-42a2-4962-acdc-22b7c6e0e7fe2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidone hydrochlorideZIPRASIDONE HYDROCHLORIDEBryant Ranch Prepack14191e0d-8219-4f6e-b808-09c4804a82622026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidone hydrochlorideZIPRASIDONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.fc9ffbc3-1f16-9265-e053-6294a90acfd22025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidone hydrochlorideZIPRASIDONE HYDROCHLORIDEBryant Ranch Prepack48e6e141-66d3-4eab-b0bf-dfd1d44b48322023-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313776ziprasidone HCl 40 MG Oral CapsulePSN7e7261d7-4902-4bb5-a268-6c358890f96318
313776ziprasidone 40 MG Oral CapsuleSCD7e7261d7-4902-4bb5-a268-6c358890f96318
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSY7e7261d7-4902-4bb5-a268-6c358890f96318

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2294-07051822940030 CAPSULE in 1 BLISTER PACK (70518-2294-0) 30 capsule2019-09-030000-00-00NoNoCurrent
70518-2294-17051822940130 POUCH in 1 BOX (70518-2294-1) / 1 CAPSULE in 1 POUCH (70518-2294-2) 30 pouch2019-10-210000-00-00NoNoCurrent
70518-2294-2705182294021 in 1 POUCHHistorical