Ziprasidone Hydrochloride
- Product NDC
- 68788-7197
- Requested package NDC
- 68788-7197-3
- 11-digit product format
- 687887197
- Labeler code
- 68788
- Product ID
- 68788-7197_c1f2fbf0-95ff-46c4-8041-a872b2ab30bb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ziprasidone Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA204375
- Marketing category
- ANDA
- Marketing start
- 2020-06-01
- Marketing end
- 0000-00-00
- Substance
- ZIPRASIDONE HYDROCHLORIDE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 68788-7197 | 68788-7197-3 | D | Discontinued by firm | 2026-08-17 |
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.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204375-001 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | |
| A204375-002 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | |
| A204375-003 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | |
| A204375-004 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-02-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204375-001 | AB |
| A204375-002 | AB |
| A204375-003 | AB |
| A204375-004 | AB |
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.
| 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 | A204375-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204375-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204375-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204375-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204375-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204375-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204375-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204375-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204375-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204375-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204375-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204375-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204375-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204375-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204375-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204375-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204375-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204375-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204375-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204375-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204375-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204375-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204375-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204375-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204375-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204375-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204375-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204375-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204375-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204375-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204375-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204375-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204375-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204375-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204375-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204375-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204375-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204375-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204375-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204375-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-02-17 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A204375-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204375-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204375-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204375-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204375-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204375-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204375-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204375-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204375-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204375-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204375-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204375-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204375-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204375-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204375-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204375-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204375-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204375-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204375-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204375-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204375-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204375-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204375-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204375-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204375-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204375-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204375-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204375-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204375-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204375-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204375-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204375-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204375-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204375-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204375-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204375-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204375-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204375-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204375-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204375-004 | AB | 1 | d8e5a09893c0… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ziprasidone Hydrochloride | ZIPRASIDONE HYDROCHLORIDE | REMEDYREPACK INC. | c9f8f635-cf3f-4c42-8bd1-45bbe19bf97e | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 204375 ANDA204375 |
| Ziprasidone Hydrochloride | ZIPRASIDONE HYDROCHLORIDE | REMEDYREPACK INC. | a66a0b25-673c-4a3d-b923-5f65a02b8ff0 | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | 204375 ANDA204375 |
| Ziprasidone Hydrochloride | ZIPRASIDONE HYDROCHLORIDE | REMEDYREPACK INC. | 4e7e2d5d-8ea8-4c25-a500-f4794542fda2 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 204375 ANDA204375 |
| Ziprasidone Hydrochloride | ZIPRASIDONE HYDROCHLORIDE | Bryant Ranch Prepack | 7c683604-b827-434d-aff3-ee2ed0565cd7 | 2026-03-11 | Boxed warning, Warnings, Adverse reactions | 204375 ANDA204375 |
| Ziprasidone Hydrochloride | ZIPRASIDONE HYDROCHLORIDE | A-S Medication Solutions | c3797145-cead-4fc4-9711-8b8623bb09f4 | 2024-11-13 | Boxed warning, Warnings, Adverse reactions | 204375 ANDA204375 |
| Ziprasidone Hydrochloride | ZIPRASIDONE HYDROCHLORIDE | Bryant Ranch Prepack | 550aca3a-5051-432e-9a3f-a2e53cbd603d | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 204375 ANDA204375 |
| Ziprasidone Hydrochloride | ZIPRASIDONE HYDROCHLORIDE | Bryant Ranch Prepack | 798631b6-b9d9-44de-9a1a-ae2cee86d531 | 2023-11-20 | Boxed warning, Warnings, Adverse reactions | 204375 ANDA204375 |
| Ziprasidone Hydrochloride | ZIPRASIDONE HYDROCHLORIDE | Bryant Ranch Prepack | fa70291d-8455-40d6-9b73-bf91880f9979 | 2023-10-25 | Boxed warning, Warnings, Adverse reactions | 204375 ANDA204375 |
| Ziprasidone Hydrochloride | ZIPRASIDONE HYDROCHLORIDE | Macleods Pharmaceuticals Limited | 3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af0 | 2023-02-24 | Boxed warning, Warnings, Adverse reactions | 204375 ANDA204375 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68788-7197-3 | 68788719703 | 30 CAPSULE in 1 BOTTLE (68788-7197-3) | 30 capsule | 2020-06-01 | 0000-00-00 | No | No | Current |