NDC 43489-101

Amlodipine Besylate

Amlodipine Besylate

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

• Product ID: 43489-101_616275c0-1bee-5bf8-e053-2991aa0a234b
• NDC: 43489-101
• Product Type: Human Prescription Drug
• Proprietary Name: Amlodipine Besylate
• Generic Name: Amlodipine Besylate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2016-05-16
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090752
• Labeler Name: Secan Pharmaceuticals, Inc.
• 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: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 43489-101-01

90 TABLET in 1 BOTTLE, PLASTIC (43489-101-01)

• Marketing Start Date: 2016-05-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43489-101-05 [43489010105]

Amlodipine Besylate TABLET

• Marketing Category: ANDA
• Application Number: ANDA090752
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-05-23

NDC 43489-101-01 [43489010101]

Amlodipine Besylate TABLET

• Marketing Category: ANDA
• Application Number: ANDA090752
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-05-23

NDC 43489-101-02 [43489010102]

Amlodipine Besylate TABLET

• Marketing Category: ANDA
• Application Number: ANDA090752
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-05-23
• Marketing End Date: 2016-07-14

NDC 43489-101-03 [43489010103]

Amlodipine Besylate TABLET

• Marketing Category: ANDA
• Application Number: ANDA090752
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-05-23

NDC 43489-101-04 [43489010104]

Amlodipine Besylate TABLET

• Marketing Category: ANDA
• Application Number: ANDA090752
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-05-23
• Marketing End Date: 2016-07-14

NDC 43489-101-06 [43489010106]

Amlodipine Besylate TABLET

• Marketing Category: ANDA
• Application Number: ANDA090752
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-05-23
• Marketing End Date: 2016-07-14

Drug Details

Active Ingredients

Ingredient	Strength
AMLODIPINE BESYLATE	10 mg/1

OpenFDA Data

• SPL SET ID: 3518853a-4c5b-4161-a178-8da7f656f009
• Manufacturer:
  • Secan Pharmaceuticals, Inc.
• UNII:
  • 864V2Q084H
• RxNorm Concept Unique ID - RxCUI:
  • 308136
  • 308135
  • 197361

Pharmacological Class

• 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