Ziprasidone Hydrochloride

Product NDC
70518-0787
Requested package NDC
70518-0787-0
11-digit product format
705180787
Labeler code
70518
Product ID
70518-0787_4b312260-703f-713e-e063-6294a90a17f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204375
Marketing category
ANDA
Marketing start
2017-10-13
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

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A204375-001ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2017-02-17
A204375-002ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-02-17
A204375-003ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-02-17
A204375-004ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-02-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204375-001AB
A204375-002AB
A204375-003AB
A204375-004AB

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 UTC2026-02A204375-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2017-02-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204375-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-02-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204375-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-02-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204375-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-02-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204375-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2017-02-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204375-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-02-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204375-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-02-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204375-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-02-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A204375-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2017-02-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204375-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-02-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204375-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-02-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204375-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-02-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204375-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2017-02-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204375-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-02-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204375-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-02-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204375-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-02-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204375-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2017-02-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204375-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-02-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204375-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-02-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204375-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-02-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204375-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2017-02-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204375-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-02-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204375-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-02-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204375-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-02-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204375-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2017-02-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204375-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-02-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204375-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-02-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204375-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-02-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204375-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2017-02-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204375-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-02-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204375-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-02-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204375-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-02-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204375-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2017-02-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204375-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-02-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204375-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-02-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204375-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-02-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204375-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2017-02-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A204375-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-02-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A204375-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-02-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A204375-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-02-17d06236e962d9…

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 UTC2026-02A204375-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204375-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204375-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204375-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204375-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204375-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204375-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204375-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204375-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204375-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204375-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204375-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204375-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204375-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204375-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204375-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204375-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204375-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204375-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204375-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204375-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204375-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204375-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204375-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204375-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204375-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204375-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204375-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204375-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204375-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204375-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204375-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204375-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204375-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204375-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204375-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204375-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204375-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204375-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204375-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Ziprasidone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZIPRASIDONE HYDROCHLORIDE40 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
313776Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c9f8f635-cf3f-4c42-8bd1-45bbe19bf97eAvailable 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
70518-0787-0Ziprasidone Hydrochloride30 in 1 BLISTER PACKCAPSULE3018
70518-0787-1Ziprasidone Hydrochloride30 in 1 BOXCAPSULE3018
70518-0787-2Ziprasidone Hydrochloride1 in 1 POUCHCAPSULE118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0787ZIPRASIDONE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 3 package rows20250502_c9f8f635-cf3f-4c42-8bd1-45bbe19bf97e.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ziprasidone HydrochlorideZIPRASIDONE HYDROCHLORIDEREMEDYREPACK INC.c9f8f635-cf3f-4c42-8bd1-45bbe19bf97e2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204375
application number: ANDA204375
ndc (package): 70518-0787-0
ndc (product): 70518-0787
ndc11 (package): 70518078700
Ziprasidone HydrochlorideZIPRASIDONE HYDROCHLORIDEREMEDYREPACK INC.a66a0b25-673c-4a3d-b923-5f65a02b8ff02026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204375
application number: ANDA204375
Ziprasidone HydrochlorideZIPRASIDONE HYDROCHLORIDEREMEDYREPACK INC.4e7e2d5d-8ea8-4c25-a500-f4794542fda22026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204375
application number: ANDA204375
Ziprasidone HydrochlorideZIPRASIDONE HYDROCHLORIDEBryant Ranch Prepack7c683604-b827-434d-aff3-ee2ed0565cd72026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204375
application number: ANDA204375
Ziprasidone HydrochlorideZIPRASIDONE HYDROCHLORIDEA-S Medication Solutionsc3797145-cead-4fc4-9711-8b8623bb09f42024-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204375
application number: ANDA204375
Ziprasidone HydrochlorideZIPRASIDONE HYDROCHLORIDEBryant Ranch Prepack550aca3a-5051-432e-9a3f-a2e53cbd603d2024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204375
application number: ANDA204375
Ziprasidone HydrochlorideZIPRASIDONE HYDROCHLORIDEBryant Ranch Prepack798631b6-b9d9-44de-9a1a-ae2cee86d5312023-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204375
application number: ANDA204375
Ziprasidone HydrochlorideZIPRASIDONE HYDROCHLORIDEBryant Ranch Prepackfa70291d-8455-40d6-9b73-bf91880f99792023-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204375
application number: ANDA204375
Ziprasidone HydrochlorideZIPRASIDONE HYDROCHLORIDEMacleods Pharmaceuticals Limited3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af02023-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204375
application number: ANDA204375

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313776ziprasidone HCl 40 MG Oral CapsulePSNc9f8f635-cf3f-4c42-8bd1-45bbe19bf97e18
313776ziprasidone 40 MG Oral CapsuleSCDc9f8f635-cf3f-4c42-8bd1-45bbe19bf97e18
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSYc9f8f635-cf3f-4c42-8bd1-45bbe19bf97e18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0787-07051807870030 CAPSULE in 1 BLISTER PACK (70518-0787-0) 30 capsule2017-10-130000-00-00NoNoCurrent