NDC 18860-723

Prialt

Ziconotide

Prialt is a Intrathecal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Jazz Pharmaceuticals, Inc.. The primary component is Ziconotide Acetate.

• Product ID: 18860-723_e1eaf98c-712f-4253-80e9-7e6f41b7e212
• NDC: 18860-723
• Product Type: Human Prescription Drug
• Proprietary Name: Prialt
• Generic Name: Ziconotide
• Dosage Form: Injection, Solution
• Route of Administration: INTRATHECAL
• Marketing Start Date: 2004-12-28
• Marketing End Date: 2022-07-31
• Marketing Category: NDA / NDA
• Application Number: NDA021060
• Labeler Name: Jazz Pharmaceuticals, Inc.
• 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

Packaging

NDC 18860-723-05

1 VIAL, GLASS in 1 CARTON (18860-723-05) > 20 mL in 1 VIAL, GLASS

• Marketing Start Date: 2004-12-28
• Marketing End Date: 2022-07-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 18860-723-05 [18860072305]

Prialt INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021060
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2004-12-28
• Marketing End Date: 2022-07-31

NDC 18860-723-06 [18860072306]

Prialt INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021060
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2004-12-28
• Marketing End Date: 2013-11-18

NDC 18860-723-11 [18860072311]

Prialt INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021060
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2004-12-28
• Marketing End Date: 2013-11-18

NDC 18860-723-10 [18860072310]

Prialt INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021060
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2004-12-28
• Marketing End Date: 2022-07-31

Drug Details

Active Ingredients

Ingredient	Strength
ZICONOTIDE ACETATE	25 ug/mL

OpenFDA Data

• SPL SET ID: 5449ca98-efb8-4c3b-8756-747b2349a472
• Manufacturer:
  • Jazz Pharmaceuticals, Inc.
• 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]
• N-Calcium Channel Receptor Antagonists [MoA]
• N-type Calcium Channel Antagonist [EPC]

NDC Crossover Matching brand name "Prialt" or generic name "Ziconotide"

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