NDC 70720-723

PRIALT

Ziconotide Acetate

PRIALT is a Intrathecal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Tersera Therapeutics Llc. The primary component is Ziconotide Acetate.

Product ID70720-723_3d41566d-29f2-4d31-9287-5f83a43df821
NDC70720-723
Product TypeHuman Prescription Drug
Proprietary NamePRIALT
Generic NameZiconotide Acetate
Dosage FormInjection, Solution
Route of AdministrationINTRATHECAL
Marketing Start Date2018-10-15
Marketing CategoryNDA / NDA
Application NumberNDA021060
Labeler NameTerSera Therapeutics LLC
Substance NameZICONOTIDE ACETATE
Active Ingredient Strength25 ug/mL
Pharm ClassesN-Calcium Channel Receptor Antagonists [MoA],N-type Calcium Channel Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70720-723-10

1 VIAL, GLASS in 1 CARTON (70720-723-10) > 20 mL in 1 VIAL, GLASS
Marketing Start Date2019-08-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70720-723-10 [70720072310]

PRIALT INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021060
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-08-15

Drug Details

Active Ingredients

IngredientStrength
ZICONOTIDE ACETATE25 ug/mL

OpenFDA Data

SPL SET ID:b025d8ed-937d-4597-9ad1-0b2f6e0ee5b1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 583453
  • 1738354
  • 1738357
  • 1738353
  • 1738358
  • 486133
  • Pharmacological Class

    • N-Calcium Channel Receptor Antagonists [MoA]
    • N-type Calcium Channel Antagonist [EPC]

    NDC Crossover Matching brand name "PRIALT" or generic name "Ziconotide Acetate"

    NDCBrand NameGeneric Name
    18860-720Prialtziconotide
    18860-722Prialtziconotide
    18860-723Prialtziconotide
    70720-720PRIALTziconotide acetate
    70720-722PRIALTziconotide acetate
    70720-723PRIALTziconotide acetate

    Trademark Results [PRIALT]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PRIALT
    PRIALT
    75909746 2806847 Live/Registered
    TERSERA THERAPEUTICS LLC
    2000-02-04

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