NDC 33342-016

Amlodipine

Amlodipine

Amlodipine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Macleods Pharmaceuticals Limited. The primary component is Amlodipine Besylate.

• Product ID: 33342-016_cf534093-9769-44f3-8570-337fad041447
• NDC: 33342-016
• Product Type: Human Prescription Drug
• Proprietary Name: Amlodipine
• Generic Name: Amlodipine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2012-04-13
• Marketing Category: ANDA / ANDA
• Application Number: ANDA201380
• Labeler Name: Macleods Pharmaceuticals Limited
• Substance Name: AMLODIPINE BESYLATE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 33342-016-12

100 TABLET in 1 CARTON (33342-016-12)

• Marketing Start Date: 2012-04-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 33342-016-12 [33342001612]

Amlodipine TABLET

• Marketing Category: ANDA
• Application Number: ANDA201380
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-04-13

NDC 33342-016-10 [33342001610]

Amlodipine TABLET

• Marketing Category: ANDA
• Application Number: ANDA201380
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-04-13

Drug Details

Active Ingredients

Ingredient	Strength
AMLODIPINE BESYLATE	10 mg/1

OpenFDA Data

• SPL SET ID: 1cec7a02-b7a5-49e1-ab64-3a4dab4149d2
• Manufacturer:
  • Macleods Pharmaceuticals Limited
• UNII:
  • 864V2Q084H
• RxNorm Concept Unique ID - RxCUI:
  • 308135
  • 197361
• UPC Code:
  • 0333342016102

Pharmacological Class

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

Medicade Reported Pricing

33342001610 AMLODIPINE BESYLATE 10 MG TAB

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
33342-015	Amlodipine	Amlodipine
33342-016	Amlodipine	Amlodipine
53808-0686	Amlodipine	AMLODIPINE BESYLATE
0615-6582	Amlodipine Besylate	Amlodipine
52652-5001	Katerzia	Amlodipine
46287-035	NORLIQVA	amlodipine