PRIALT
- Product NDC
- 68118-720
- Requested package NDC
- 68118-720-10
- 11-digit product format
- 681180720
- Labeler code
- 68118
- Product ID
- 68118-720_5b88b034-162b-73cd-e063-6394a90a7fb3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ziconotide acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRATHECAL
- Labeler
- ESTEVE PHARMACEUTICALS, S.A.
- Application
- NDA021060
- Marketing category
- NDA
- Marketing start
- 2018-10-15
- 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
- 2027-12-31
- Current FDA listing
- Yes
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.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PRIALT
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZICONOTIDE ACETATE | 100 ug/mL |
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 68118-720-10 68118-720 68118072010 |
| 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 | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 68118-720-10 | 68118072010 | 1 VIAL, GLASS in 1 CARTON (68118-720-10) / 1 mL in 1 VIAL, GLASS | 2019-08-15 | No | No | Current |