NDC 42582-314

AMLODIPINE BESYLATE 5 mg

Amlodipine Besylate

AMLODIPINE BESYLATE 5 mg is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bi-coastal Pharma International Llc. The primary component is Amlodipine Besylate.

• Product ID: 42582-314_fbea5b50-8303-4614-8dcc-40b761ea17b3
• NDC: 42582-314
• Product Type: Human Prescription Drug
• Proprietary Name: AMLODIPINE BESYLATE 5 mg
• Generic Name: Amlodipine Besylate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2016-10-05
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077516
• Labeler Name: Bi-Coastal Pharma International LLC
• Substance Name: AMLODIPINE BESYLATE
• Active Ingredient Strength: 5 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 42582-314-09

90 TABLET in 1 BOTTLE (42582-314-09)

• Marketing Start Date: 2016-10-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42582-314-18 [42582031418]

AMLODIPINE BESYLATE 5 mg TABLET

• Marketing Category: ANDA
• Application Number: ANDA077516
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-10-05

NDC 42582-314-09 [42582031409]

AMLODIPINE BESYLATE 5 mg TABLET

• Marketing Category: ANDA
• Application Number: ANDA077516
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-10-05

Drug Details

Active Ingredients

Ingredient	Strength
AMLODIPINE BESYLATE	5 mg/1

OpenFDA Data

• SPL SET ID: 705d4471-b1bc-49a7-a871-9c03f886b69e
• Manufacturer:
  • Bi-Coastal Pharma International LLC
• UNII:
  • 864V2Q084H
• RxNorm Concept Unique ID - RxCUI:
  • 308136
  • 308135
  • 197361
• UPC Code:
  • 0342582315098
  • 0342582314091
  • 0342582313094

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 "AMLODIPINE BESYLATE 5 mg" or generic name "Amlodipine Besylate"

NDC	Brand Name	Generic Name
42582-314	AMLODIPINE BESYLATE 5 mg	AMLODIPINE BESYLATE 5 mg
62980-507	AMLODIPINE BESYLATE 5 mg	AMLODIPINE BESYLATE 5 mg
0054-0100	Amlodipine Besylate	Amlodipine Besylate
0054-0101	Amlodipine Besylate	Amlodipine Besylate
0054-0102	Amlodipine Besylate	Amlodipine Besylate
0093-0083	Amlodipine Besylate	Amlodipine Besylate
0093-7167	Amlodipine Besylate	Amlodipine Besylate
0093-7168	Amlodipine Besylate	Amlodipine Besylate
0143-9959	Amlodipine besylate	Amlodipine besylate
0143-9960	Amlodipine besylate	Amlodipine besylate
0143-9961	Amlodipine besylate	Amlodipine besylate
0179-0210	Amlodipine Besylate	Amlodipine Besylate
0179-0211	Amlodipine Besylate	Amlodipine Besylate
0179-0213	Amlodipine Besylate	Amlodipine Besylate
0378-5208	Amlodipine Besylate	amlodipine besylate
0378-5209	Amlodipine Besylate	amlodipine besylate
0378-5210	Amlodipine Besylate	amlodipine besylate
0480-0083	Amlodipine Besylate	Amlodipine Besylate
0480-7167	Amlodipine Besylate	Amlodipine Besylate
0480-7168	Amlodipine Besylate	Amlodipine Besylate
0603-2108	Amlodipine Besylate	amlodipine besylate
0603-2109	Amlodipine Besylate	amlodipine besylate
0603-2110	Amlodipine Besylate	amlodipine besylate
0615-6577	Amlodipine Besylate	amlodipine besylate
0615-6578	Amlodipine Besylate	amlodipine besylate
0615-7939	Amlodipine Besylate	Amlodipine Besylate
0615-7941	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE
0615-7942	Amlodipine Besylate	Amlodipine Besylate
0615-8199	Amlodipine Besylate	Amlodipine Besylate
0615-8200	Amlodipine Besylate	Amlodipine Besylate
0615-8201	Amlodipine Besylate	Amlodipine Besylate
0615-8282	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE
0069-1520	Norvasc	amlodipine besylate
0069-1530	Norvasc	amlodipine besylate
0069-1540	Norvasc	amlodipine besylate