NDC 61919-852

AMOLDIPINE BENAZEPRIL HCL

Amoldipine Benazepril Hcl

AMOLDIPINE BENAZEPRIL HCL is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Directrx. The primary component is Amlodipine Besylate; Benazepril Hydrochloride.

Product ID61919-852_871e47cb-a829-9ba7-e053-2991aa0a96ea
NDC61919-852
Product TypeHuman Prescription Drug
Proprietary NameAMOLDIPINE BENAZEPRIL HCL
Generic NameAmoldipine Benazepril Hcl
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-04-22
Marketing CategoryANDA / ANDA
Application NumberANDA202239
Labeler NameDirectRX
Substance NameAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active Ingredient Strength10 mg/1; mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61919-852-90

90 CAPSULE in 1 BOTTLE (61919-852-90)
Marketing Start Date2019-04-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-852-90 [61919085290]

AMOLDIPINE BENAZEPRIL HCL CAPSULE
Marketing CategoryANDA
Application NumberANDA202239
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-22

Drug Details

Active Ingredients

IngredientStrength
AMLODIPINE BESYLATE10 mg/1

OpenFDA Data

SPL SET ID:871e47cb-a828-9ba7-e053-2991aa0a96ea
Manufacturer
UNII

Pharmacological Class

  • Calcium Channel Antagonists [MoA]
  • Dihydropyridine Calcium Channel Blocker [EPC]
  • Dihydropyridines [CS]
  • Angiotensin Converting Enzyme Inhibitor [EPC]
  • Angiotensin-converting Enzyme Inhibitors [MoA]
  • Decreased Blood Pressure [PE]
  • Calcium Channel Antagonists [MoA]
  • Dihydropyridine Calcium Channel Blocker [EPC]
  • Dihydropyridines [CS]
  • Angiotensin Converting Enzyme Inhibitor [EPC]
  • Angiotensin-converting Enzyme Inhibitors [MoA]
  • Decreased Blood Pressure [PE]

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.