NDC 0078-0563

Exforge HCT

Amlodipine Valsartan And Hydrochlorothiazide

Exforge HCT 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; Hydrochlorothiazide.

• Product ID: 0078-0563_10b0a131-e828-48e1-9e2b-92a6bbcb753a
• NDC: 0078-0563
• Product Type: Human Prescription Drug
• Proprietary Name: Exforge HCT
• Generic Name: Amlodipine Valsartan And Hydrochlorothiazide
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2009-04-04
• Marketing Category: NDA / NDA
• Application Number: NDA022314
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE
• Active Ingredient Strength: 10 mg/1; 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],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0078-0563-15

30 TABLET, FILM COATED in 1 BOTTLE (0078-0563-15)

• Marketing Start Date: 2009-04-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0563-34 [00078056334]

Exforge HCT TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022314
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-04-04
• Marketing End Date: 2014-06-19

NDC 0078-0563-30 [00078056330]

Exforge HCT TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022314
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-04-04
• Marketing End Date: 2019-04-30

NDC 0078-0563-15 [00078056315]

Exforge HCT TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022314
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-04-04

Drug Details

Active Ingredients

Ingredient	Strength
AMLODIPINE BESYLATE	10 mg/1

OpenFDA Data

• SPL SET ID: 18d7820d-471f-4ee2-9ec6-25d8d27c77de
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 864V2Q084H
  • 0J48LPH2TH
  • 80M03YXJ7I
• RxNorm Concept Unique ID - RxCUI:
  • 848131
  • 848151
  • 848135
  • 848155
  • 848145
  • 848144
  • 848134
  • 848140
  • 848139
  • 848149
• UPC Code:
  • 0300780563154
  • 0300780560153
  • 0300780561150

Pharmacological Class

• Calcium Channel Antagonists [MoA]
• Dihydropyridine Calcium Channel Blocker [EPC]
• Dihydropyridines [CS]
• Angiotensin 2 Receptor Antagonists [MoA]
• Angiotensin 2 Receptor Blocker [EPC]
• Increased Diuresis [PE]
• Thiazide Diuretic [EPC]
• Thiazides [CS]

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

NDC	Brand Name	Generic Name
0078-0559	Exforge HCT	amlodipine valsartan and hydrochlorothiazide
0078-0560	Exforge HCT	amlodipine valsartan and hydrochlorothiazide
0078-0561	Exforge HCT	amlodipine valsartan and hydrochlorothiazide
0078-0562	Exforge HCT	amlodipine valsartan and hydrochlorothiazide
0078-0563	Exforge HCT	amlodipine valsartan and hydrochlorothiazide
0781-5756	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine valsartan and hydrochlorothiazide
0781-5760	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine valsartan and hydrochlorothiazide
0781-5771	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine valsartan and hydrochlorothiazide
0781-5787	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine valsartan and hydrochlorothiazide
0781-5794	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine valsartan and hydrochlorothiazide