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 ID: 70720-723_3d41566d-29f2-4d31-9287-5f83a43df821
• NDC: 70720-723
• Product Type: Human Prescription Drug
• Proprietary Name: PRIALT
• Generic Name: Ziconotide Acetate
• Dosage Form: Injection, Solution
• Route of Administration: INTRATHECAL
• Marketing Start Date: 2018-10-15
• Marketing Category: NDA / NDA
• Application Number: NDA021060
• Labeler Name: TerSera Therapeutics LLC
• Substance Name: ZICONOTIDE ACETATE
• Active Ingredient Strength: 25 ug/mL
• Pharm Classes: N-Calcium Channel Receptor Antagonists [MoA],N-type Calcium Channel Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 70720-723-10

1 VIAL, GLASS in 1 CARTON (70720-723-10) > 20 mL in 1 VIAL, GLASS

• Marketing Start Date: 2019-08-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70720-723-10 [70720072310]

PRIALT INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021060
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-08-15

Drug Details

Active Ingredients

Ingredient	Strength
ZICONOTIDE ACETATE	25 ug/mL

OpenFDA Data

• SPL SET ID: b025d8ed-937d-4597-9ad1-0b2f6e0ee5b1
• Manufacturer:
  • TerSera Therapeutics LLC
• UNII:
  • T2I226K69M
• 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"

NDC	Brand Name	Generic Name
18860-720	Prialt	ziconotide
18860-722	Prialt	ziconotide
18860-723	Prialt	ziconotide
70720-720	PRIALT	ziconotide acetate
70720-722	PRIALT	ziconotide acetate
70720-723	PRIALT	ziconotide acetate