NDC 67544-403

Diovan

Valsartan

Diovan is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Valsartan.

• Product ID: 67544-403_948ffea7-be2c-4b21-9880-8e27af9a4090
• NDC: 67544-403
• Product Type: Human Prescription Drug
• Proprietary Name: Diovan
• Generic Name: Valsartan
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2001-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA021283
• Labeler Name: Aphena Pharma Solutions - Tennessee, LLC
• Substance Name: VALSARTAN
• Active Ingredient Strength: 80 mg/1
• Pharm Classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 67544-403-79

6030 TABLET in 1 BOTTLE, PLASTIC (67544-403-79)

• Marketing Start Date: 2001-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67544-403-30 [67544040330]

Diovan TABLET

• Marketing Category: NDA
• Application Number: NDA021283
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2001-07-01
• Inactivation Date: 2020-01-31

NDC 67544-403-79 [67544040379]

Diovan TABLET

• Marketing Category: NDA
• Application Number: NDA021283
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-05-09
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
VALSARTAN	80 mg/1

OpenFDA Data

• SPL SET ID: c6488119-6547-4abd-bc15-a809b6107d4f
• Manufacturer:
  • Aphena Pharma Solutions - Tennessee, LLC
• UNII:
  • 80M03YXJ7I
• RxNorm Concept Unique ID - RxCUI:
  • 349201
  • 351761
  • 351762
  • 349199

Pharmacological Class

• Angiotensin 2 Receptor Antagonists [MoA]
• Angiotensin 2 Receptor Blocker [EPC]

NDC Crossover Matching brand name "Diovan" or generic name "Valsartan"

NDC	Brand Name	Generic Name
0078-0358	Diovan	valsartan
0078-0359	Diovan	valsartan
0078-0360	Diovan	valsartan
0078-0423	Diovan	valsartan
68151-5044	Diovan	Diovan
68151-4349	Diovan	Diovan
21695-917	Diovan	Diovan
21695-918	Diovan	Diovan
21695-919	Diovan	Diovan
55289-825	Diovan	Diovan
55289-817	Diovan	Diovan
55289-876	Diovan	Diovan
67544-403	Diovan	Diovan
67544-404	Diovan	Diovan
0378-5807	Valsartan	valsartan
0378-5813	Valsartan	valsartan
0378-5814	Valsartan	valsartan
0378-5815	Valsartan	valsartan
0591-2167	Valsartan	valsartan
0591-2168	Valsartan	valsartan
0591-2169	Valsartan	valsartan
0591-2170	Valsartan	valsartan
0781-5607	Valsartan	valsartan
0781-5608	Valsartan	valsartan
0781-5618	Valsartan	valsartan
0781-5619	Valsartan	valsartan
0904-6594	Valsartan	valsartan
0904-6595	Valsartan	valsartan
10135-768	Valsartan	Valsartan
10135-769	Valsartan	Valsartan
10135-770	Valsartan	Valsartan
10135-771	Valsartan	Valsartan