FDA.reportPublic FDA data

PRIALT

Product NDC
70720-723
11-digit product format
707200723
Labeler code
70720
Product ID
70720-723_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
25 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

Additional Listing Data#

Finished product
Yes
Brand name base
PRIALT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZICONOTIDE ACETATE25 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT2I226K69M
Rxcui486133, 583453, 1738353, 1738354, 1738357, 1738358

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
cfe7f319-4c0f-d232-09c5-fe18e53b1f38Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70720-723-10PRIALT1 in 1 CARTONINJECTION, SOLUTION16
70720-723-10PRIALT20 mL in 1 VIAL, GLASSINJECTION, SOLUTION206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70720-723-10ML - Milliliter70720-7235f99dc85-c46d-4795-9b45-4a0479af1a1a12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70720-723PRIALT (ZICONOTIDE ACETATE) INJECTION, SOLUTION [TERSERA THERAPEUTICS LLC]5Current NDC, Legacy NDC, 2 package rows20231201_b025d8ed-937d-4597-9ad1-0b2f6e0ee5b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738354prialt 100 MCG in 1 ML InjectionPSNb025d8ed-937d-4597-9ad1-0b2f6e0ee5b16
583453prialt 500 MCG in 20 ML InjectionPSNb025d8ed-937d-4597-9ad1-0b2f6e0ee5b16
1738358prialt 500 MCG in 5 ML InjectionPSNb025d8ed-937d-4597-9ad1-0b2f6e0ee5b16
1738353ziconotide 100 MCG in 1 ML InjectionPSNb025d8ed-937d-4597-9ad1-0b2f6e0ee5b16
1738357ziconotide 500 MCG in 5 ML InjectionPSNb025d8ed-937d-4597-9ad1-0b2f6e0ee5b16
486133ziconotide acetate 500 MCG in 20 ML InjectionPSNb025d8ed-937d-4597-9ad1-0b2f6e0ee5b16
17383541 ML ziconotide acetate 0.1 MG/ML Injection [Prialt]SBDb025d8ed-937d-4597-9ad1-0b2f6e0ee5b16
58345320 ML ziconotide acetate 0.025 MG/ML Injection [Prialt]SBDb025d8ed-937d-4597-9ad1-0b2f6e0ee5b16
17383585 ML ziconotide acetate 0.1 MG/ML Injection [Prialt]SBDb025d8ed-937d-4597-9ad1-0b2f6e0ee5b16
17383531 ML ziconotide acetate 0.1 MG/ML InjectionSCDb025d8ed-937d-4597-9ad1-0b2f6e0ee5b16
48613320 ML ziconotide acetate 0.025 MG/ML InjectionSCDb025d8ed-937d-4597-9ad1-0b2f6e0ee5b16
17383575 ML ziconotide acetate 0.1 MG/ML InjectionSCDb025d8ed-937d-4597-9ad1-0b2f6e0ee5b16
1738354Prialt 100 MCG per 1 ML InjectionSYb025d8ed-937d-4597-9ad1-0b2f6e0ee5b16
583453Prialt 500 MCG per 20 ML InjectionSYb025d8ed-937d-4597-9ad1-0b2f6e0ee5b16
1738358Prialt 500 MCG per 5 ML InjectionSYb025d8ed-937d-4597-9ad1-0b2f6e0ee5b16
1738353ziconotide 100 MCG per 1 ML InjectionSYb025d8ed-937d-4597-9ad1-0b2f6e0ee5b16
1738357ziconotide 500 MCG per 5 ML InjectionSYb025d8ed-937d-4597-9ad1-0b2f6e0ee5b16
486133ziconotide acetate 500 MCG per 20 ML InjectionSYb025d8ed-937d-4597-9ad1-0b2f6e0ee5b16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70720-723-10707200723101 VIAL, GLASS in 1 CARTON (70720-723-10) / 20 mL in 1 VIAL, GLASS2019-08-150000-00-00NoNoCurrent