ziprasidone hydrochloride
- Product NDC
- 0781-2168
- Requested package NDC
- 0781-2168-60
- 11-digit product format
- 007812168
- Labeler code
- 0781
- Product ID
- 0781-2168_7df70d10-a688-4718-9364-ac4915dec366
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ziprasidone hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA077562
- Marketing category
- ANDA
- Marketing start
- 2013-02-13
- 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
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 | 0781-2168 | 0781-2168-60 | 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 | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0781-2168 | 0781-2168-60 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077562-001 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | |
| A077562-002 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | |
| A077562-003 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | |
| A077562-004 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-06-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077562-001 | AB |
| A077562-002 | AB |
| A077562-003 | AB |
| A077562-004 | 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 | A077562-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077562-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077562-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077562-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077562-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077562-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077562-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077562-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077562-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077562-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077562-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077562-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077562-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077562-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077562-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077562-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077562-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077562-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077562-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077562-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077562-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077562-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077562-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077562-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077562-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077562-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077562-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077562-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077562-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077562-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077562-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077562-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077562-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077562-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077562-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077562-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077562-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077562-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077562-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077562-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-06-01 | 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 | A077562-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077562-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077562-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077562-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077562-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077562-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077562-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077562-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077562-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077562-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077562-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077562-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077562-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077562-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077562-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077562-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077562-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077562-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077562-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077562-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077562-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077562-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077562-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077562-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077562-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077562-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077562-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077562-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077562-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077562-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077562-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077562-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077562-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077562-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077562-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077562-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077562-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077562-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077562-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077562-004 | AB | 1 | d8e5a09893c0… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| defe29d6-6a09-c3aa-4400-b1130380ccc3 | Product name | 5 | 20231206 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0781-2168-60 | EA - Each | 0781-2168 | 6d2f8d77-b49a-496f-8318-dc2548e05f18 | 1 | 2013-03-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313778 | ziprasidone HCl 80 MG Oral Capsule | PSN | 0721cc7e-9560-4ca4-95e1-5c3a4d32c572 | 6 |
| 313778 | ziprasidone 80 MG Oral Capsule | SCD | 0721cc7e-9560-4ca4-95e1-5c3a4d32c572 | 6 |
| 313778 | ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral Capsule | SY | 0721cc7e-9560-4ca4-95e1-5c3a4d32c572 | 6 |
| 314286 | ziprasidone HCl 20 MG Oral Capsule | PSN | 5752ef72-c515-4ead-a359-69d4761ad7f4 | 4 |
| 313778 | ziprasidone HCl 80 MG Oral Capsule | PSN | 5752ef72-c515-4ead-a359-69d4761ad7f4 | 4 |
| 314286 | ziprasidone 20 MG Oral Capsule | SCD | 5752ef72-c515-4ead-a359-69d4761ad7f4 | 4 |
| 313778 | ziprasidone 80 MG Oral Capsule | SCD | 5752ef72-c515-4ead-a359-69d4761ad7f4 | 4 |
| 314286 | ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral Capsule | SY | 5752ef72-c515-4ead-a359-69d4761ad7f4 | 4 |
| 313778 | ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral Capsule | SY | 5752ef72-c515-4ead-a359-69d4761ad7f4 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0781-2168-60 | 00781216860 | 60 CAPSULE in 1 BOTTLE (0781-2168-60) | 60 capsule | 2013-02-13 | 0000-00-00 | No | No | Current |