Prialt

Product NDC
18860-723
Requested package NDC
18860-723-05
11-digit product format
188600723
Labeler code
18860
Product ID
18860-723_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
2022-07-31
Substance
ZICONOTIDE ACETATE
Active strength
25 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.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage18860-72318860-723-05DDiscontinued by firm2026-08-11

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021060-001PRIALTZICONOTIDE ACETATE500MCG/20ML (25MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-28
N021060-002PRIALTZICONOTIDE ACETATE100MCG/1ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-28
N021060-003PRIALTZICONOTIDE ACETATE200MCG/2ML (100MCG/ML)INJECTABLE / INTRATHECAL2004-12-28
N021060-004PRIALTZICONOTIDE ACETATE500MCG/5ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-28

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.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021060-001PRIALT500MCG/20ML (25MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021060-002PRIALT100MCG/1ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021060-003PRIALT200MCG/2ML (100MCG/ML)INJECTABLE / INTRATHECAL2004-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021060-004PRIALT500MCG/5ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021060-001PRIALT500MCG/20ML (25MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021060-002PRIALT100MCG/1ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021060-003PRIALT200MCG/2ML (100MCG/ML)INJECTABLE / INTRATHECAL2004-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021060-004PRIALT500MCG/5ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021060-001PRIALT500MCG/20ML (25MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021060-002PRIALT100MCG/1ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021060-003PRIALT200MCG/2ML (100MCG/ML)INJECTABLE / INTRATHECAL2004-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021060-004PRIALT500MCG/5ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021060-001PRIALT500MCG/20ML (25MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021060-002PRIALT100MCG/1ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021060-003PRIALT200MCG/2ML (100MCG/ML)INJECTABLE / INTRATHECAL2004-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021060-004PRIALT500MCG/5ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021060-001PRIALT500MCG/20ML (25MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021060-002PRIALT100MCG/1ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021060-003PRIALT200MCG/2ML (100MCG/ML)INJECTABLE / INTRATHECAL2004-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021060-004PRIALT500MCG/5ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-001PRIALT500MCG/20ML (25MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-002PRIALT100MCG/1ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-003PRIALT200MCG/2ML (100MCG/ML)INJECTABLE / INTRATHECAL2004-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-004PRIALT500MCG/5ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-001PRIALT500MCG/20ML (25MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-002PRIALT100MCG/1ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-003PRIALT200MCG/2ML (100MCG/ML)INJECTABLE / INTRATHECAL2004-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-004PRIALT500MCG/5ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021060-001PRIALT500MCG/20ML (25MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021060-002PRIALT100MCG/1ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021060-003PRIALT200MCG/2ML (100MCG/ML)INJECTABLE / INTRATHECAL2004-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021060-004PRIALT500MCG/5ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021060-001PRIALT500MCG/20ML (25MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021060-002PRIALT100MCG/1ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021060-003PRIALT200MCG/2ML (100MCG/ML)INJECTABLE / INTRATHECAL2004-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021060-004PRIALT500MCG/5ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021060-001PRIALT500MCG/20ML (25MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N021060-002PRIALT100MCG/1ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N021060-003PRIALT200MCG/2ML (100MCG/ML)INJECTABLE / INTRATHECAL2004-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N021060-004PRIALT500MCG/5ML (100MCG/ML)INJECTABLE / INTRATHECALRLD, RS2004-12-28d06236e962d9…

Observed Orange Book patent history#

Patent history page 1 of 18 · 700 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-00186530332024-10-01U-552014-02-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-00186530332024-10-01U-482014-02-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-00187656802024-10-01U-552014-07-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-00187656802024-10-01U-482014-07-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-00197072702024-10-01U-20842017-08-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-00286530332024-10-01U-482014-02-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-00286530332024-10-01U-552014-02-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-00287656802024-10-01U-482014-07-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-00287656802024-10-01U-552014-07-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-00297072702024-10-01U-20842017-08-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-00386530332024-10-01U-482014-02-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-00386530332024-10-01U-552014-02-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-00387656802024-10-01U-482014-07-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-00387656802024-10-01U-552014-07-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-00397072702024-10-01U-20842017-08-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-00486530332024-10-01U-552014-02-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-00486530332024-10-01U-482014-02-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-00487656802024-10-01U-482014-07-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-00487656802024-10-01U-552014-07-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021060-00497072702024-10-01U-20842017-08-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-00186530332024-10-01U-552014-02-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-00186530332024-10-01U-482014-02-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-00187656802024-10-01U-552014-07-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-00187656802024-10-01U-482014-07-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-00197072702024-10-01U-20842017-08-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-00286530332024-10-01U-482014-02-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-00286530332024-10-01U-552014-02-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-00287656802024-10-01U-482014-07-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-00287656802024-10-01U-552014-07-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-00297072702024-10-01U-20842017-08-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-00386530332024-10-01U-482014-02-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-00386530332024-10-01U-552014-02-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-00387656802024-10-01U-482014-07-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-00387656802024-10-01U-552014-07-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-00397072702024-10-01U-20842017-08-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-00486530332024-10-01U-552014-02-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-00486530332024-10-01U-482014-02-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-00487656802024-10-01U-482014-07-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-00487656802024-10-01U-552014-07-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021060-00497072702024-10-01U-20842017-08-162680178bc6a6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
18860-723-10ML - Milliliter18860-723eda66542-0d53-40d5-aa0f-26d4c03daecd12012-07-24

DailyMed Socrata Ingredients#

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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRIALTZICONOTIDE ACETATEESTEVE PHARMACEUTICALS, S.A.57376a5b-4530-9018-e063-6394a90a9afe2026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021060
application number: NDA021060
PRIALTZICONOTIDE ACETATETerSera Therapeutics LLCb025d8ed-937d-4597-9ad1-0b2f6e0ee5b12025-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021060
application number: NDA021060

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
18860-723-05188600723051 VIAL, GLASS in 1 CARTON (18860-723-05) > 20 mL in 1 VIAL, GLASS2004-12-282022-07-31NoNoCurrent