NDC 0078-0384

Lotrel

Amlodipine Besylate And Benazepril Hydrochloride

Lotrel is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Amlodipine Besylate; Benazepril Hydrochloride.

• Product ID: 0078-0384_46cca24f-f00e-4616-8d39-f0a2812ec2d1
• NDC: 0078-0384
• Product Type: Human Prescription Drug
• Proprietary Name: Lotrel
• Generic Name: Amlodipine Besylate And Benazepril Hydrochloride
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1995-03-03
• Marketing Category: NDA / NDA
• Application Number: NDA020364
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/1; mg/1
• Pharm Classes: 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]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0078-0384-05

100 CAPSULE in 1 BOTTLE (0078-0384-05)

• Marketing Start Date: 1995-03-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0384-05 [00078038405]

Lotrel CAPSULE

• Marketing Category: NDA
• Application Number: NDA020364
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1995-03-03
• Marketing End Date: 2016-06-30

Drug Details

Active Ingredients

Ingredient	Strength
AMLODIPINE BESYLATE	5 mg/1

OpenFDA Data

• SPL SET ID: 94ae6054-b7ae-4212-a567-4f803af8f2c7
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 864V2Q084H
  • N1SN99T69T
• RxNorm Concept Unique ID - RxCUI:
  • 898359
  • 898361
  • 898342
  • 898344
  • 898346
  • 898358
  • 898348
  • 898356
  • 898355
  • 898353
  • 898352
  • 898350
• UPC Code:
  • 0300780406055

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]

NDC Crossover Matching brand name "Lotrel" or generic name "Amlodipine Besylate And Benazepril Hydrochloride"

NDC	Brand Name	Generic Name
0078-0364	Lotrel	amlodipine besylate and benazepril hydrochloride
0078-0379	Lotrel	amlodipine besylate and benazepril hydrochloride
0078-0384	Lotrel	amlodipine besylate and benazepril hydrochloride
0078-0404	Lotrel	amlodipine besylate and benazepril hydrochloride
0078-0405	Lotrel	amlodipine besylate and benazepril hydrochloride
0078-0406	Lotrel	amlodipine besylate and benazepril hydrochloride
55289-096	Lotrel	Lotrel
55289-039	Lotrel	Lotrel
0615-1397	amlodipine besylate and benazepril hydrochloride	amlodipine besylate and benazepril hydrochloride
0615-1398	amlodipine besylate and benazepril hydrochloride	amlodipine besylate and benazepril hydrochloride
0615-1399	amlodipine besylate and benazepril hydrochloride	amlodipine besylate and benazepril hydrochloride
0781-2271	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride
0781-2272	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride
0781-2273	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride
0781-2274	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride
0781-2277	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride
0781-2279	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride
33261-823	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride
33261-824	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride
33261-825	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride
33261-982	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride
42254-073	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride
42254-074	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride
43063-233	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride
43063-571	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride
49884-929	Amlodipine besylate and benazepril hydrochloride	amlodipine besylate and benazepril hydrochloride
49884-930	Amlodipine besylate and benazepril hydrochloride	amlodipine besylate and benazepril hydrochloride