Home NDC 70720-722 PRIALT
Product NDC 70720-722
11-digit product format 707200722
Labeler code 70720
Product ID 70720-722_a7101558-afb8-443b-8c26-a238e26bb40c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ziconotide acetate
Dosage form INJECTION, SOLUTION
Route INTRATHECAL
Labeler TerSera Therapeutics LLC
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 2026-12-31
Current FDA listing Yes 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…
Additional Listing Data#
Finished product Yes
Brand name base PRIALT
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZICONOTIDE ACETATE 100 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination T2I226K69M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 486133 Internal RxNorm lookup 583453 Internal RxNorm lookup 1738353 Internal RxNorm lookup 1738354 Internal RxNorm lookup 1738357 Internal RxNorm lookup 1738358 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70720-722-10 PRIALT 1 in 1 CARTON INJECTION, SOLUTION 1 6 70720-722-10 PRIALT 5 mL in 1 VIAL, GLASS INJECTION, SOLUTION 5 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70720-722 PRIALT (ZICONOTIDE ACETATE) INJECTION, SOLUTION [TERSERA THERAPEUTICS LLC] 5 Current NDC, Legacy NDC, 2 package rows 20231201_b025d8ed-937d-4597-9ad1-0b2f6e0ee5b1.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70720-722-10 70720072210 1 VIAL, GLASS in 1 CARTON (70720-722-10) / 5 mL in 1 VIAL, GLASS 2019-08-15 0000-00-00 No No Current