Home NDC 72578-128 Ziprasidone
Product NDC 72578-128
11-digit product format 725780128
Labeler code 72578
Product ID 72578-128_e02b7585-27db-4f92-a018-4ed89374da48
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ziprasidone
Dosage form CAPSULE
Route ORAL
Labeler Viona Pharmaceuticals Inc
Application ANDA208988
Marketing category ANDA
Marketing start 2020-09-15
Marketing end 0000-00-00
Substance ZIPRASIDONE HYDROCHLORIDE
Active strength 80 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 72578-128-80 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 72578-128-14 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 72578-128-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 72578-128-80 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 72578-128-14 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 72578-128-05 f5e01cc5f278…a2eaf40c39c3…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208988-001 ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2017-08-22 A208988-002 ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-08-22 A208988-003 ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-08-22 A208988-004 ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-08-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A208988-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2017-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208988-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208988-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208988-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-08-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208988-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2017-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208988-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208988-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208988-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208988-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2017-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208988-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208988-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208988-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208988-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2017-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208988-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208988-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208988-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208988-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2017-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208988-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208988-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208988-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208988-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2017-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208988-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208988-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208988-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208988-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2017-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208988-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208988-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208988-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208988-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2017-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208988-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208988-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208988-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208988-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2017-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208988-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208988-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208988-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208988-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2017-08-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208988-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2017-08-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208988-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2017-08-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208988-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2017-08-22 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 152 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72578-128 ZIPRASIDONE CAPSULE [VIONA PHARMACEUTICALS INC] 5 Legacy NDC 20221225_8f78b278-a0b3-47ce-bbad-5dad7012896a.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72578-128-05 72578012805 500 CAPSULE in 1 BOTTLE (72578-128-05) 500 capsule 2020-09-15 0000-00-00 No No Current 72578-128-14 72578012814 60 CAPSULE in 1 BOTTLE (72578-128-14) 60 capsule 2020-09-15 0000-00-00 No No Current 72578-128-80 72578012880 8 BLISTER PACK in 1 CARTON (72578-128-80) > 10 CAPSULE in 1 BLISTER PACK 8 blister pack 2020-09-15 0000-00-00 No No Current