ziprasidone hydrochloride

Product NDC
68071-3418
Requested package NDC
68071-3418-9
11-digit product format
680713418
Labeler code
68071
Product ID
68071-3418_2d6c5430-64f8-bbe9-e063-6294a90aed50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077565
Marketing category
ANDA
Marketing start
2012-03-02
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 3 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
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-341868071-3418-9UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-341868071-3418-9UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-341868071-3418-9UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-10-29 15:01 UTC2024-10A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-02d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-10-29 15:01 UTC2024-10A077565-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077565-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077565-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077565-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZIPRASIDONE HYDROCHLORIDE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
216X081ORUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
314286Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fc9ffbc3-1f16-9265-e053-6294a90acfd2Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3418-9ziprasidone hydrochloride90 in 1 BOTTLECAPSULE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3418ZIPRASIDONE HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.]3Current NDC, 1 package rows20250207_fc9ffbc3-1f16-9265-e053-6294a90acfd2.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-a258-039a6779a1a22026-07-29Boxed 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
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
ZiprasidoneZIPRASIDONEMajor Pharmaceuticalsca55c149-5b9a-4144-b586-37cb5e84dc4e2025-08-26Boxed 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
ndc (package): 68071-3418-9
ndc (product): 68071-3418
ndc11 (package): 68071341809
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
314286ziprasidone HCl 20 MG Oral CapsulePSNfc9ffbc3-1f16-9265-e053-6294a90acfd23
314286ziprasidone 20 MG Oral CapsuleSCDfc9ffbc3-1f16-9265-e053-6294a90acfd23
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSYfc9ffbc3-1f16-9265-e053-6294a90acfd23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3418-96807134180990 CAPSULE in 1 BOTTLE (68071-3418-9) 90 capsule2023-05-26NoNoCurrent