NDC 52652-5001

Katerzia

Amlodipine

Katerzia is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Azurity Pharmaceuticals, Inc.. The primary component is Amlodipine Benzoate.

• Product ID: 52652-5001_2ddc59f1-dc68-420a-889b-245b54144430
• NDC: 52652-5001
• Product Type: Human Prescription Drug
• Proprietary Name: Katerzia
• Generic Name: Amlodipine
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2019-08-15
• Marketing Category: NDA / NDA
• Application Number: NDA211340
• Labeler Name: Azurity Pharmaceuticals, Inc.
• Substance Name: AMLODIPINE BENZOATE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 52652-5001-1

1 BOTTLE in 1 CARTON (52652-5001-1) > 150 mL in 1 BOTTLE

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

NDC SPL Data Element Entries

NDC 52652-5001-1 [52652500101]

Katerzia SUSPENSION

• Marketing Category: NDA
• Application Number: NDA211340
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-08-15

Drug Details

Active Ingredients

Ingredient	Strength
AMLODIPINE	1 mg/mL

OpenFDA Data

• SPL SET ID: df673a4d-acb8-444c-a472-c87ab8cbd366
• Manufacturer:
  • Silvergate Pharmaceuticals, Inc.
• UNII:
  • 1J444QC288
• RxNorm Concept Unique ID - RxCUI:
  • 2184120
  • 2184126
• UPC Code:
  • 9311612100110

Pharmacological Class

• Calcium Channel Antagonists [MoA]
• Dihydropyridine Calcium Channel Blocker [EPC]
• Dihydropyridines [CS]
• Calcium Channel Antagonists [MoA]
• Dihydropyridine Calcium Channel Blocker [EPC]
• Dihydropyridines [CS]

NDC Crossover Matching brand name "Katerzia" or generic name "Amlodipine"

NDC	Brand Name	Generic Name
52652-5001	Katerzia	Amlodipine
33342-015	Amlodipine	Amlodipine
33342-016	Amlodipine	Amlodipine
0615-6582	Amlodipine Besylate	Amlodipine
46287-035	NORLIQVA	amlodipine