NDC 0078-0383

Diovan HCT

Valsartan And Hydrochlorothiazide

Diovan 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 Valsartan; Hydrochlorothiazide.

• Product ID: 0078-0383_0fa1a408-909e-4098-96ac-2bef1bd97298
• NDC: 0078-0383
• Product Type: Human Prescription Drug
• Proprietary Name: Diovan HCT
• Generic Name: Valsartan And Hydrochlorothiazide
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 1998-03-06
• Marketing Category: NDA / NDA
• Application Number: NDA020818
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: VALSARTAN; HYDROCHLOROTHIAZIDE
• Active Ingredient Strength: 160 mg/1; mg/1
• Pharm Classes: 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: 2021-12-31

Packaging

NDC 0078-0383-34

90 TABLET, FILM COATED in 1 BOTTLE (0078-0383-34)

• Marketing Start Date: 1998-03-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0383-61 [00078038361]

Diovan HCT TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020818
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-04-06

NDC 0078-0383-15 [00078038315]

Diovan HCT TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020818
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-03-06
• Marketing End Date: 2017-05-31

NDC 0078-0383-34 [00078038334]

Diovan HCT TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020818
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-03-06

NDC 0078-0383-67 [00078038367]

Diovan HCT TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020818
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-01-25
• Marketing End Date: 2015-08-10

NDC 0078-0383-17 [00078038317]

Diovan HCT TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020818
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-08-29
• Marketing End Date: 2015-08-10

NDC 0078-0383-06 [00078038306]

Diovan HCT TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020818
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-03-06
• Marketing End Date: 2015-08-10

Drug Details

Active Ingredients

Ingredient	Strength
VALSARTAN	160 mg/1

OpenFDA Data

• SPL SET ID: d76a0419-05ee-437e-884c-65807aea9569
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 0J48LPH2TH
  • 80M03YXJ7I
• RxNorm Concept Unique ID - RxCUI:
  • 809026
  • 809022
  • 636045
  • 636042
  • 809018
  • 809030
  • 809014
  • 200285
  • 200284
  • 349353
• UPC Code:
  • 0300780315340
  • 0300780383349
  • 0300780314343

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0078-0314	Diovan HCT	valsartan and hydrochlorothiazide
0078-0315	Diovan HCT	valsartan and hydrochlorothiazide
0078-0383	Diovan HCT	valsartan and hydrochlorothiazide
0078-0471	Diovan HCT	valsartan and hydrochlorothiazide
0078-0472	Diovan HCT	valsartan and hydrochlorothiazide
68258-6056	Diovan HCT	Diovan HCT
68258-6053	Diovan HCT	Diovan HCT
68258-6972	Diovan HCT	Diovan HCT
68258-6973	Diovan HCT	Diovan HCT
55289-820	Diovan HCT	Diovan HCT
55289-838	Diovan HCT	Diovan HCT
0378-6321	Valsartan and Hydrochlorothiazide	valsartan and hydrochlorothiazide
0378-6322	Valsartan and Hydrochlorothiazide	valsartan and hydrochlorothiazide
0378-6323	Valsartan and Hydrochlorothiazide	valsartan and hydrochlorothiazide