prialt

Generic: ziconotide acetate

Labeler: tersera therapeutics llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name prialt
Generic Name ziconotide acetate
Labeler tersera therapeutics llc
Dosage Form INJECTION, SOLUTION
Routes
INTRATHECAL
Active Ingredients

ziconotide acetate 100 ug/mL

Manufacturer
TerSera Therapeutics LLC

Identifiers & Regulatory

Product NDC 70720-720
Product ID 70720-720_a7101558-afb8-443b-8c26-a238e26bb40c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021060
Listing Expiration 2026-12-31
Marketing Start 2018-10-15

Pharmacologic Class

Classes
n-calcium channel receptor antagonists [moa] n-type calcium channel antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70720720
Hyphenated Format 70720-720

Supplemental Identifiers

RxCUI
486133 583453 1738353 1738354 1738357 1738358
UNII
T2I226K69M

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name prialt (source: ndc)
Generic Name ziconotide acetate (source: ndc)
Application Number NDA021060 (source: ndc)
Routes
INTRATHECAL
source: ndc

Resolved Composition

Strengths
  • 100 ug/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (70720-720-10) / 1 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

70720-720-10 1 VIAL, GLASS in 1 CARTON (70720-720-10) / 1 mL in 1 VIAL, GLASS

Ingredients (1)

ziconotide acetate (100 ug/mL)

Linked Drug Pages (1)

PRIALT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRATHECAL"], "spl_id": "a7101558-afb8-443b-8c26-a238e26bb40c", "openfda": {"unii": ["T2I226K69M"], "rxcui": ["486133", "583453", "1738353", "1738354", "1738357", "1738358"], "spl_set_id": ["b025d8ed-937d-4597-9ad1-0b2f6e0ee5b1"], "manufacturer_name": ["TerSera Therapeutics LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (70720-720-10)  / 1 mL in 1 VIAL, GLASS", "package_ndc": "70720-720-10", "marketing_start_date": "20190815"}], "brand_name": "PRIALT", "product_id": "70720-720_a7101558-afb8-443b-8c26-a238e26bb40c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["N-Calcium Channel Receptor Antagonists [MoA]", "N-type Calcium Channel Antagonist [EPC]"], "product_ndc": "70720-720", "generic_name": "ziconotide acetate", "labeler_name": "TerSera Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PRIALT", "active_ingredients": [{"name": "ZICONOTIDE ACETATE", "strength": "100 ug/mL"}], "application_number": "NDA021060", "marketing_category": "NDA", "marketing_start_date": "20181015", "listing_expiration_date": "20261231"}