Ziprasidone hydrochloride

Product NDC
55648-991
11-digit product format
556480991
Labeler code
55648
Product ID
55648-991_a1ced08e-5f3f-4d84-a39f-507734086ae2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ziprasidone hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA090348
Marketing category
ANDA
Marketing start
2012-09-01
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
2019-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55648-991IInactivated by FDA2026-08-03
excluded packagepackage55648-99155648-991-01IInactivated by FDA2026-08-03
excluded packagepackage55648-99155648-991-02IInactivated by FDA2026-08-03
excluded packagepackage55648-99155648-991-03IInactivated by FDA2026-08-03
excluded packagepackage55648-99155648-991-04IInactivated by FDA2026-08-03
excluded packagepackage55648-99155648-991-06IInactivated by FDA2026-08-03

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 3 · 126 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-991-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-991-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-991-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-991-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-991-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-991-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-991-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-991-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-991-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-991-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-991-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-991-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-991-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-991-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-991-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-991-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-991-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-991-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-991-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-991-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-991-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-991-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-991-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-991-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-991-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-991-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-991-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-991-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-991-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-991-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-991-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-991-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-991-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-991-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-991-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-991-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-991-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-991-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-991-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-991-06ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-991-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-991-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-991-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-991-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-991-060efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-991-04ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-991-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-991-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-991-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-991-06ad56d346431e…cc804d4bbf1e…

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
A090348-001ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-09-05
A090348-002ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-09-05
A090348-003ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-09-05
A090348-004ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-09-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090348-001AB
A090348-002AB
A090348-003AB
A090348-004AB

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 UTC2026-02A090348-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090348-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090348-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090348-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090348-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090348-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090348-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090348-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090348-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090348-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090348-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090348-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090348-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090348-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090348-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090348-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090348-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090348-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090348-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090348-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090348-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090348-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090348-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090348-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090348-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090348-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090348-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090348-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090348-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090348-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090348-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090348-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-09-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090348-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090348-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090348-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090348-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-09-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090348-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-09-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A090348-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-09-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A090348-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-09-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A090348-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-09-05d06236e962d9…

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 UTC2026-02A090348-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090348-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090348-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090348-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090348-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090348-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090348-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090348-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090348-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090348-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090348-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090348-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090348-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090348-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090348-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090348-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090348-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090348-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090348-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090348-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090348-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090348-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090348-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090348-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090348-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090348-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090348-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090348-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090348-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090348-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090348-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090348-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090348-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090348-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090348-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090348-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090348-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090348-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090348-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090348-004AB1d06236e962d9…

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
55648-991-01Ziprasidone hydrochloride30 in 1 BOTTLECAPSULE301
55648-991-02Ziprasidone hydrochloride60 in 1 BOTTLECAPSULE601
55648-991-03Ziprasidone hydrochloride100 in 1 BOTTLECAPSULE1001
55648-991-04Ziprasidone hydrochloride500 in 1 BOTTLECAPSULE5001
55648-991-06Ziprasidone hydrochloride10 in 1 CARTONCAPSULE101
55648-991-06Ziprasidone hydrochloride8 in 1 BLISTER PACKCAPSULE81

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZIPRASIDONE HYDROCHLORIDEACTIVE INGREDIENT216X081ORUZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
ZIPRASIDONEACTIVE MOIETY6UKA5VEJ6XZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
GELATININACTIVE INGREDIENT2G86QN327LZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1UZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-991ZIPRASIDONE HYDROCHLORIDE CAPSULE [WOCKHARDT LIMITED]1Legacy NDC, 6 package rows20120906_81ca60c4-376b-43b7-b050-09e328fc403c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZiprasidoneZIPRASIDONEChartwell RX, LLC7fbd9460-78a3-4160-9986-3a113de752a62023-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090348
application number: ANDA090348

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314286ziprasidone HCl 20 MG Oral CapsulePSN81ca60c4-376b-43b7-b050-09e328fc403c1
313776ziprasidone HCl 40 MG Oral CapsulePSN81ca60c4-376b-43b7-b050-09e328fc403c1
313777ziprasidone HCl 60 MG Oral CapsulePSN81ca60c4-376b-43b7-b050-09e328fc403c1
313778ziprasidone HCl 80 MG Oral CapsulePSN81ca60c4-376b-43b7-b050-09e328fc403c1
314286ziprasidone 20 MG Oral CapsuleSCD81ca60c4-376b-43b7-b050-09e328fc403c1
313776ziprasidone 40 MG Oral CapsuleSCD81ca60c4-376b-43b7-b050-09e328fc403c1
313777ziprasidone 60 MG Oral CapsuleSCD81ca60c4-376b-43b7-b050-09e328fc403c1
313778ziprasidone 80 MG Oral CapsuleSCD81ca60c4-376b-43b7-b050-09e328fc403c1
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSY81ca60c4-376b-43b7-b050-09e328fc403c1
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSY81ca60c4-376b-43b7-b050-09e328fc403c1
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSY81ca60c4-376b-43b7-b050-09e328fc403c1
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSY81ca60c4-376b-43b7-b050-09e328fc403c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-991-015564809910130 in 1 BOTTLEHistorical
55648-991-025564809910260 in 1 BOTTLEHistorical
55648-991-0355648099103100 in 1 BOTTLEHistorical
55648-991-0455648099104500 in 1 BOTTLEHistorical
55648-991-065564809910610 in 1 CARTONHistorical