NDC 0378-5208

Amlodipine Besylate

Amlodipine Besylate

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

• Product ID: 0378-5208_2bca2c4d-60f5-438a-951c-c9ef69f98d48
• NDC: 0378-5208
• Product Type: Human Prescription Drug
• Proprietary Name: Amlodipine Besylate
• Generic Name: Amlodipine Besylate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2005-10-03
• Marketing End Date: 2020-06-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076418
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: AMLODIPINE BESYLATE
• Active Ingredient Strength: 3 mg/1
• Pharm Classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
• NDC Exclude Flag: N

Packaging

NDC 0378-5208-05

500 TABLET in 1 BOTTLE, PLASTIC (0378-5208-05)

• Marketing Start Date: 2005-10-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-5208-77 [00378520877]

Amlodipine Besylate TABLET

• Marketing Category: ANDA
• Application Number: ANDA076418
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-10-03
• Marketing End Date: 2020-06-30

NDC 0378-5208-05 [00378520805]

Amlodipine Besylate TABLET

• Marketing Category: ANDA
• Application Number: ANDA076418
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-10-03
• Marketing End Date: 2020-06-30

Drug Details

Active Ingredients

Ingredient	Strength
AMLODIPINE BESYLATE	2.5 mg/1

OpenFDA Data

• SPL SET ID: a4ab4f05-1c18-442a-8618-c2c92e589703
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 864V2Q084H
• RxNorm Concept Unique ID - RxCUI:
  • 308136
  • 308135
  • 197361
• UPC Code:
  • 0303785210771
  • 0303785209775
  • 0303785208778

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" or generic name "Amlodipine Besylate"

NDC	Brand Name	Generic Name
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
0615-6582	Amlodipine Besylate	Amlodipine
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
67544-979	Amlodipine Besylate	Amlodipine Besylate
67544-993	Amlodipine Besylate	Amlodipine Besylate
67877-198	Amlodipine Besylate	Amlodipine Besylate
67877-197	Amlodipine Besylate	Amlodipine Besylate
67877-199	Amlodipine Besylate	Amlodipine Besylate
68071-1902	Amlodipine Besylate	Amlodipine Besylate
68071-1974	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE
68071-1924	Amlodipine Besylate	Amlodipine Besylate
68071-1903	Amlodipine Besylate	Amlodipine Besylate
68071-3188	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE
68071-1980	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE
68071-4251	Amlodipine Besylate	Amlodipine Besylate
68071-3327	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE
68071-4776	Amlodipine Besylate	Amlodipine Besylate
68151-0995	Amlodipine Besylate	Amlodipine Besylate
68180-720	Amlodipine Besylate	Amlodipine Besylate
68180-750	Amlodipine Besylate	Amlodipine Besylate
68180-721	Amlodipine Besylate	Amlodipine Besylate
68180-752	Amlodipine Besylate	Amlodipine Besylate