Ziprasidone

Product NDC
70518-3376
Requested package NDC
70518-3376-0
11-digit product format
705183376
Labeler code
70518
Product ID
70518-3376_f0d2ddca-ee8f-7a31-e053-2995a90a5faa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA020825
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-03-02
Marketing end
0000-00-00
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-337670518-3376-0DDiscontinued 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 · 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 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
N020825-001GEODONZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALABRLD, RS2001-02-05
N020825-002GEODONZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALABRLD2001-02-05
N020825-003GEODONZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALABRLD2001-02-05
N020825-004GEODONZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALABRLD2001-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020825-001AB
N020825-002AB
N020825-003AB
N020825-004AB

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 06:07:402026-07N020825-001GEODONEQ 20MG BASECAPSULE / ORALABRLD, RS2001-02-05caaa826d4ba7…
2026-08-18 06:07:402026-07N020825-002GEODONEQ 40MG BASECAPSULE / ORALABRLD2001-02-05caaa826d4ba7…
2026-08-18 06:07:402026-07N020825-003GEODONEQ 60MG BASECAPSULE / ORALABRLD2001-02-05caaa826d4ba7…
2026-08-18 06:07:402026-07N020825-004GEODONEQ 80MG BASECAPSULE / ORALABRLD2001-02-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020825-001GEODONEQ 20MG BASECAPSULE / ORALABRLD, RS2001-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020825-002GEODONEQ 40MG BASECAPSULE / ORALABRLD2001-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020825-003GEODONEQ 60MG BASECAPSULE / ORALABRLD2001-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020825-004GEODONEQ 80MG BASECAPSULE / ORALABRLD2001-02-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020825-001GEODONEQ 20MG BASECAPSULE / ORALABRLD, RS2001-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020825-002GEODONEQ 40MG BASECAPSULE / ORALABRLD2001-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020825-003GEODONEQ 60MG BASECAPSULE / ORALABRLD2001-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020825-004GEODONEQ 80MG BASECAPSULE / ORALABRLD2001-02-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N020825-001GEODONEQ 20MG BASECAPSULE / ORALABRLD, RS2001-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020825-002GEODONEQ 40MG BASECAPSULE / ORALABRLD2001-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020825-003GEODONEQ 60MG BASECAPSULE / ORALABRLD2001-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020825-004GEODONEQ 80MG BASECAPSULE / ORALABRLD2001-02-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020825-001GEODONEQ 20MG BASECAPSULE / ORALABRLD, RS2001-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020825-002GEODONEQ 40MG BASECAPSULE / ORALABRLD2001-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020825-003GEODONEQ 60MG BASECAPSULE / ORALABRLD2001-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020825-004GEODONEQ 80MG BASECAPSULE / ORALABRLD2001-02-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020825-001GEODONEQ 20MG BASECAPSULE / ORALABRLD, RS2001-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020825-002GEODONEQ 40MG BASECAPSULE / ORALABRLD2001-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020825-003GEODONEQ 60MG BASECAPSULE / ORALABRLD2001-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020825-004GEODONEQ 80MG BASECAPSULE / ORALABRLD2001-02-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020825-001GEODONEQ 20MG BASECAPSULE / ORALABRLD, RS2001-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020825-002GEODONEQ 40MG BASECAPSULE / ORALABRLD2001-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020825-003GEODONEQ 60MG BASECAPSULE / ORALABRLD2001-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020825-004GEODONEQ 80MG BASECAPSULE / ORALABRLD2001-02-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020825-001GEODONEQ 20MG BASECAPSULE / ORALABRLD, RS2001-02-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020825-002GEODONEQ 40MG BASECAPSULE / ORALABRLD2001-02-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020825-003GEODONEQ 60MG BASECAPSULE / ORALABRLD2001-02-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020825-004GEODONEQ 80MG BASECAPSULE / ORALABRLD2001-02-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020825-001GEODONEQ 20MG BASECAPSULE / ORALABRLD, RS2001-02-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020825-002GEODONEQ 40MG BASECAPSULE / ORALABRLD2001-02-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020825-003GEODONEQ 60MG BASECAPSULE / ORALABRLD2001-02-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020825-004GEODONEQ 80MG BASECAPSULE / ORALABRLD2001-02-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020825-001GEODONEQ 20MG BASECAPSULE / ORALABRLD, RS2001-02-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020825-002GEODONEQ 40MG BASECAPSULE / ORALABRLD2001-02-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020825-003GEODONEQ 60MG BASECAPSULE / ORALABRLD2001-02-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020825-004GEODONEQ 80MG BASECAPSULE / ORALABRLD2001-02-05d8e5a09893c0…

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 06:07:402026-07N020825-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020825-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020825-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020825-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020825-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020825-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020825-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020825-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020825-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020825-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020825-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020825-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020825-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020825-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020825-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020825-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020825-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020825-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020825-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020825-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020825-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020825-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020825-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020825-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020825-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020825-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020825-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020825-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020825-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020825-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020825-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020825-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020825-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020825-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020825-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020825-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020825-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020825-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020825-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020825-004AB1d8e5a09893c0…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N020825-00161503662019-05-27Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020825-00261503662019-05-27Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020825-00361503662019-05-27Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020825-00461503662019-05-27Drug product74a2ff9319b5…
2019-12-14 00:12 UTC2019-12N020825-00161503662019-05-27Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N020825-00261503662019-05-27Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N020825-00361503662019-05-27Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N020825-00461503662019-05-27Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N020825-00161503662019-05-27Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N020825-00261503662019-05-27Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N020825-00361503662019-05-27Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N020825-00461503662019-05-27Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N020825-00161503662019-05-27Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N020825-00261503662019-05-27Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N020825-00361503662019-05-27Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N020825-00461503662019-05-27Drug productea99ee380514…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 116 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020825-001M-2322025-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020825-002M-2322025-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020825-003M-2322025-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020825-004M-2322025-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020825-001M-2322025-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020825-002M-2322025-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020825-003M-2322025-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020825-004M-2322025-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020825-001M-2322025-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020825-002M-2322025-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020825-003M-2322025-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020825-004M-2322025-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020825-001M-2322025-01-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020825-002M-2322025-01-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020825-003M-2322025-01-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020825-004M-2322025-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020825-001M-2322025-01-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020825-002M-2322025-01-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020825-003M-2322025-01-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020825-004M-2322025-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020825-001M-2322025-01-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020825-002M-2322025-01-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020825-003M-2322025-01-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020825-004M-2322025-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020825-001M-2322025-01-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020825-002M-2322025-01-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020825-003M-2322025-01-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020825-004M-2322025-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020825-001M-2322025-01-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020825-002M-2322025-01-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020825-003M-2322025-01-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020825-004M-2322025-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020825-001M-2322025-01-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N020825-002M-2322025-01-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N020825-003M-2322025-01-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N020825-004M-2322025-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020825-001M-2322025-01-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020825-002M-2322025-01-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020825-003M-2322025-01-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020825-004M-2322025-01-2879d66fd596c7…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GeodonZIPRASIDONEViatris Specialty LLCa2b4cc65-6a6d-49c4-adfc-a4458562a1672025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020825
application number: NDA020825
GeodonZIPRASIDONE HYDROCHLORIDEROERIG8326928a-2cb6-4f7f-9712-03a425a14c372025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020825
application number: NDA020825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3376-07051833760030 CAPSULE in 1 BLISTER PACK (70518-3376-0) 30 capsule2022-03-020000-00-00NoNoCurrent