NDC 0078-0489

Exforge

Amlodipine Besylate And Valsartan

Exforge is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Amlodipine Besylate; Valsartan.

• Product ID: 0078-0489_16f31180-e5cf-4747-95a8-2d0fd218a9b6
• NDC: 0078-0489
• Product Type: Human Prescription Drug
• Proprietary Name: Exforge
• Generic Name: Amlodipine Besylate And Valsartan
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2007-06-20
• Marketing Category: NDA / NDA
• Application Number: NDA021990
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: AMLODIPINE BESYLATE; VALSARTAN
• Active Ingredient Strength: 10 mg/1; mg/1
• Pharm Classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0078-0489-15

30 TABLET, FILM COATED in 1 BOTTLE (0078-0489-15)

• Marketing Start Date: 2007-06-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0489-15 [00078048915]

Exforge TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021990
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-06-20

NDC 0078-0489-35 [00078048935]

Exforge TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021990
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2007-06-20
• Marketing End Date: 2011-01-31

NDC 0078-0489-30 [00078048930]

Exforge TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021990
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-06-19
• Marketing End Date: 2015-08-11

NDC 0078-0489-34 [00078048934]

Exforge TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021990
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2007-06-20
• Marketing End Date: 2014-06-19

NDC 0078-0489-61 [00078048961]

Exforge TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021990
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-05-20
• Marketing End Date: 2011-01-31

Drug Details

Active Ingredients

Ingredient	Strength
AMLODIPINE BESYLATE	10 mg/1

OpenFDA Data

• SPL SET ID: d0caec89-96ec-411d-a933-63eda74a6da7
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 864V2Q084H
  • 80M03YXJ7I
• RxNorm Concept Unique ID - RxCUI:
  • 724895
  • 722131
  • 724879
  • 724887
  • 724891
  • 722137
  • 722126
  • 722134
• UPC Code:
  • 0300780491150

Pharmacological Class

• Calcium Channel Antagonists [MoA]
• Dihydropyridine Calcium Channel Blocker [EPC]
• Dihydropyridines [CS]
• Angiotensin 2 Receptor Antagonists [MoA]
• Angiotensin 2 Receptor Blocker [EPC]

NDC Crossover Matching brand name "Exforge" or generic name "Amlodipine Besylate And Valsartan"

NDC	Brand Name	Generic Name
0078-0488	Exforge	amlodipine besylate and valsartan
0078-0489	Exforge	amlodipine besylate and valsartan
0078-0490	Exforge	amlodipine besylate and valsartan
0078-0491	Exforge	amlodipine besylate and valsartan
0781-5615	AMLODIPINE AND VALSARTAN	amlodipine besylate and valsartan
0781-5628	AMLODIPINE AND VALSARTAN	amlodipine besylate and valsartan
0781-5639	AMLODIPINE AND VALSARTAN	amlodipine besylate and valsartan
0781-5643	AMLODIPINE AND VALSARTAN	amlodipine besylate and valsartan
50090-2471	AMLODIPINE AND VALSARTAN	amlodipine besylate and valsartan