Prialt
- Product NDC
- 18860-722
- 11-digit product format
- 188600722
- Labeler code
- 18860
- Product ID
- 18860-722_e1eaf98c-712f-4253-80e9-7e6f41b7e212
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ziconotide
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRATHECAL
- Labeler
- Jazz Pharmaceuticals, Inc.
- Application
- NDA021060
- Marketing category
- NDA
- Marketing start
- 2004-12-28
- Marketing end
- 2022-08-31
- Substance
- ZICONOTIDE ACETATE
- Active strength
- 100 ug/mL
- Pharmacologic classes
- N-Calcium Channel Receptor Antagonists [MoA],N-type Calcium Channel Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 product | product | 18860-722 | D | Discontinued by firm | 2026-10-05 | ||
| excluded product | product | 18860-722 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 18860-722 | 18860-722-11 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 18860-722 | 18860-722-10 | D | Discontinued by firm | 2026-10-05 |
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 | 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 product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 18860-722-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 18860-722-11 | 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 product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 18860-722-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 18860-722-11 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 18860-722-10 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 18860-722-11 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 18860-722-10 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 18860-722-11 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 18860-722-10 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 18860-722-11 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 18860-722-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 18860-722-11 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 18860-722-10 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 18860-722-11 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 18860-722-10 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 18860-722-11 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 18860-722-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 18860-722-11 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 18860-722-10 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 18860-722-11 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 18860-722-10 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 18860-722-11 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 18860-722-10 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 18860-722-11 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021060-001 | PRIALT | ZICONOTIDE ACETATE | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | |
| N021060-002 | PRIALT | ZICONOTIDE ACETATE | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | |
| N021060-003 | PRIALT | ZICONOTIDE ACETATE | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | ||
| N021060-004 | PRIALT | ZICONOTIDE ACETATE | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021060-001 | PRIALT | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021060-002 | PRIALT | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021060-003 | PRIALT | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021060-004 | PRIALT | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021060-001 | PRIALT | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021060-002 | PRIALT | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021060-003 | PRIALT | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021060-004 | PRIALT | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021060-001 | PRIALT | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021060-002 | PRIALT | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021060-003 | PRIALT | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021060-004 | PRIALT | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021060-001 | PRIALT | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021060-002 | PRIALT | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021060-003 | PRIALT | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021060-004 | PRIALT | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021060-001 | PRIALT | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021060-002 | PRIALT | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021060-003 | PRIALT | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021060-004 | PRIALT | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021060-001 | PRIALT | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021060-002 | PRIALT | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021060-003 | PRIALT | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021060-004 | PRIALT | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021060-001 | PRIALT | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021060-002 | PRIALT | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021060-003 | PRIALT | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021060-004 | PRIALT | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-001 | PRIALT | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-002 | PRIALT | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-003 | PRIALT | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-004 | PRIALT | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-001 | PRIALT | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-002 | PRIALT | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-003 | PRIALT | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-004 | PRIALT | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021060-001 | PRIALT | 500MCG/20ML (25MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021060-002 | PRIALT | 100MCG/1ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021060-003 | PRIALT | 200MCG/2ML (100MCG/ML) | INJECTABLE / INTRATHECAL | 2004-12-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021060-004 | PRIALT | 500MCG/5ML (100MCG/ML) | INJECTABLE / INTRATHECAL | RLD, RS | 2004-12-28 | 5bbf6a4d5a75… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-001 | 8653033 | 2024-10-01 | U-55 | 2014-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-001 | 8653033 | 2024-10-01 | U-48 | 2014-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-001 | 8765680 | 2024-10-01 | U-55 | 2014-07-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-001 | 8765680 | 2024-10-01 | U-48 | 2014-07-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-001 | 9707270 | 2024-10-01 | U-2084 | 2017-08-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-002 | 8653033 | 2024-10-01 | U-48 | 2014-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-002 | 8653033 | 2024-10-01 | U-55 | 2014-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-002 | 8765680 | 2024-10-01 | U-48 | 2014-07-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-002 | 8765680 | 2024-10-01 | U-55 | 2014-07-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-002 | 9707270 | 2024-10-01 | U-2084 | 2017-08-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-003 | 8653033 | 2024-10-01 | U-48 | 2014-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-003 | 8653033 | 2024-10-01 | U-55 | 2014-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-003 | 8765680 | 2024-10-01 | U-48 | 2014-07-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-003 | 8765680 | 2024-10-01 | U-55 | 2014-07-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-003 | 9707270 | 2024-10-01 | U-2084 | 2017-08-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-004 | 8653033 | 2024-10-01 | U-55 | 2014-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-004 | 8653033 | 2024-10-01 | U-48 | 2014-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-004 | 8765680 | 2024-10-01 | U-48 | 2014-07-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-004 | 8765680 | 2024-10-01 | U-55 | 2014-07-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021060-004 | 9707270 | 2024-10-01 | U-2084 | 2017-08-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-001 | 8653033 | 2024-10-01 | U-55 | 2014-02-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-001 | 8653033 | 2024-10-01 | U-48 | 2014-02-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-001 | 8765680 | 2024-10-01 | U-55 | 2014-07-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-001 | 8765680 | 2024-10-01 | U-48 | 2014-07-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-001 | 9707270 | 2024-10-01 | U-2084 | 2017-08-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-002 | 8653033 | 2024-10-01 | U-48 | 2014-02-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-002 | 8653033 | 2024-10-01 | U-55 | 2014-02-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-002 | 8765680 | 2024-10-01 | U-48 | 2014-07-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-002 | 8765680 | 2024-10-01 | U-55 | 2014-07-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-002 | 9707270 | 2024-10-01 | U-2084 | 2017-08-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-003 | 8653033 | 2024-10-01 | U-48 | 2014-02-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-003 | 8653033 | 2024-10-01 | U-55 | 2014-02-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-003 | 8765680 | 2024-10-01 | U-48 | 2014-07-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-003 | 8765680 | 2024-10-01 | U-55 | 2014-07-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-003 | 9707270 | 2024-10-01 | U-2084 | 2017-08-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-004 | 8653033 | 2024-10-01 | U-55 | 2014-02-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-004 | 8653033 | 2024-10-01 | U-48 | 2014-02-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-004 | 8765680 | 2024-10-01 | U-48 | 2014-07-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-004 | 8765680 | 2024-10-01 | U-55 | 2014-07-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021060-004 | 9707270 | 2024-10-01 | U-2084 | 2017-08-16 | 2680178bc6a6… |
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 | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 18860-722-10 | ML - Milliliter | 18860-722 | 1d9bcf67-4d91-406a-827b-d94754dc6a5c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ziconotide acetate | ACTIVE INGREDIENT | T2I226K69M | PRIALT (ZICONOTIDE) INJECTION, SOLUTION [JAZZ PHARMACEUTICALS, INC.] | 5 | |
| ZICONOTIDE | ACTIVE MOIETY | 7I64C51O16 | PRIALT (ZICONOTIDE) INJECTION, SOLUTION [JAZZ PHARMACEUTICALS, INC.] | 5 | |
| METHIONINE | INACTIVE INGREDIENT | AE28F7PNPL | PRIALT (ZICONOTIDE) INJECTION, SOLUTION [JAZZ PHARMACEUTICALS, INC.] | 5 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | PRIALT (ZICONOTIDE) INJECTION, SOLUTION [JAZZ PHARMACEUTICALS, INC.] | 5 |
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 |
|---|---|---|---|---|---|---|
| PRIALT | ZICONOTIDE ACETATE | ESTEVE PHARMACEUTICALS, S.A. | 57376a5b-4530-9018-e063-6394a90a9afe | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | 021060 NDA021060 |
| PRIALT | ZICONOTIDE ACETATE | TerSera Therapeutics LLC | b025d8ed-937d-4597-9ad1-0b2f6e0ee5b1 | 2025-05-31 | Boxed warning, Warnings, Adverse reactions | 021060 NDA021060 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 18860-722-10 | 18860072210 | 1 VIAL, GLASS in 1 CARTON (18860-722-10) > 5 mL in 1 VIAL, GLASS | 2004-12-28 | 2022-08-31 | No | No | Current |