Ziprasidone

Product NDC
59762-1006
Requested package NDC
59762-1006-1
11-digit product format
597621006
Labeler code
59762
Product ID
59762-1006_7ed20469-8ba9-41cf-8d36-ffca3b728dc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone
Dosage form
CAPSULE
Route
ORAL
Labeler
Greenstone LLC
Application
NDA020825
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-11-03
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 packagepackage59762-100659762-1006-1DDiscontinued by firm2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020825-001GEODONEQ 20MG BASECAPSULE / ORALABRLD, RS2001-02-0584e616aacf4f…
2026-09-14 22:38:342026-08N020825-002GEODONEQ 40MG BASECAPSULE / ORALABRLD2001-02-0584e616aacf4f…
2026-09-14 22:38:342026-08N020825-003GEODONEQ 60MG BASECAPSULE / ORALABRLD2001-02-0584e616aacf4f…
2026-09-14 22:38:342026-08N020825-004GEODONEQ 80MG BASECAPSULE / ORALABRLD2001-02-0584e616aacf4f…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N020825-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N020825-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N020825-003AB184e616aacf4f…
2026-09-14 22:38:342026-08N020825-004AB184e616aacf4f…
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…

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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-1006-1EA - Each59762-100625350a83-ed7b-44ca-b471-7873e7a5992112021-12-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZIPRASIDONE HYDROCHLORIDEACTIVE INGREDIENT216X081ORUZIPRASIDONE (ZIPRASIDONE HYDROCHLORIDE) CAPSULE [GREENSTONE LLC]9
ZIPRASIDONEACTIVE MOIETY6UKA5VEJ6XZIPRASIDONE (ZIPRASIDONE HYDROCHLORIDE) CAPSULE [GREENSTONE LLC]9
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GZIPRASIDONE (ZIPRASIDONE HYDROCHLORIDE) CAPSULE [GREENSTONE LLC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIPRASIDONE (ZIPRASIDONE HYDROCHLORIDE) CAPSULE [GREENSTONE LLC]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-1006ZIPRASIDONE (ZIPRASIDONE HYDROCHLORIDE) CAPSULE ZIPRASIDONE CAPSULE [MYLAN PHARMACEUTICALS INC.]27Legacy NDC20250504_315e24c2-2f8c-47d9-b1b1-ce006646098a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-1006-15976210060160 CAPSULE in 1 BOTTLE (59762-1006-1) 60 capsule2021-11-030000-00-00NoNoCurrent