Home NDC 18860-723 Prialt
Product NDC 18860-723
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 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 2 · 72 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-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.
Product history page 1 of 5 · 164 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 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…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021060-001 PRIALT 500MCG/20ML (25MCG/ML) INJECTABLE / INTRATHECAL RLD, RS 2004-12-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021060-002 PRIALT 100MCG/1ML (100MCG/ML) INJECTABLE / INTRATHECAL RLD, RS 2004-12-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021060-003 PRIALT 200MCG/2ML (100MCG/ML) INJECTABLE / INTRATHECAL 2004-12-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021060-004 PRIALT 500MCG/5ML (100MCG/ML) INJECTABLE / INTRATHECAL RLD, RS 2004-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021060-001 PRIALT 500MCG/20ML (25MCG/ML) INJECTABLE / INTRATHECAL RLD, RS 2004-12-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021060-002 PRIALT 100MCG/1ML (100MCG/ML) INJECTABLE / INTRATHECAL RLD, RS 2004-12-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021060-003 PRIALT 200MCG/2ML (100MCG/ML) INJECTABLE / INTRATHECAL 2004-12-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021060-004 PRIALT 500MCG/5ML (100MCG/ML) INJECTABLE / INTRATHECAL RLD, RS 2004-12-28 d06236e962d9…
Observed Orange Book patent history# Patent history page 1 of 18 · 700 observed states.
Captured, Edition, Application-product table 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…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table 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.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 18860-723-05 18860072305 1 VIAL, GLASS in 1 CARTON (18860-723-05) > 20 mL in 1 VIAL, GLASS 2004-12-28 2022-07-31 No No Current 18860-723-10 18860072310 1 VIAL, GLASS in 1 CARTON (18860-723-10) > 20 mL in 1 VIAL, GLASS 2004-12-28 2022-07-31 No No Current