Ziprasidone Hydrochloride

Product NDC
63629-8150
Requested package NDC
63629-8150-2
11-digit product format
636298150
Labeler code
63629
Product ID
63629-8150_ea2b746e-ebf2-4ae2-9921-06b28cb310ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204375
Marketing category
ANDA
Marketing start
2017-02-18
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 · 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
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-815063629-8150-2IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204375-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2017-02-17caaa826d4ba7…
2026-08-18 06:07:402026-07A204375-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2017-02-17caaa826d4ba7…
2026-08-18 06:07:402026-07A204375-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2017-02-17caaa826d4ba7…
2026-08-18 06:07:402026-07A204375-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2017-02-17caaa826d4ba7…
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…

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 06:07:402026-07A204375-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204375-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204375-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204375-004AB1caaa826d4ba7…
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…

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
550aca3a-5051-432e-9a3f-a2e53cbd603dAvailable 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
63629-8150-1Ziprasidone Hydrochloride30 in 1 BOTTLECAPSULE305
63629-8150-2Ziprasidone Hydrochloride60 in 1 BOTTLECAPSULE605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8150ZIPRASIDONE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 2 package rows20240514_550aca3a-5051-432e-9a3f-a2e53cbd603d.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
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
ndc (package): 63629-8150-2
ndc (product): 63629-8150
ndc11 (package): 63629815002
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
314286ziprasidone HCl 20 MG Oral CapsulePSN550aca3a-5051-432e-9a3f-a2e53cbd603d5
314286ziprasidone 20 MG Oral CapsuleSCD550aca3a-5051-432e-9a3f-a2e53cbd603d5
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSY550aca3a-5051-432e-9a3f-a2e53cbd603d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8150-26362981500260 CAPSULE in 1 BOTTLE (63629-8150-2) 60 capsule2019-06-180000-00-00NoNoCurrent