FDA.reportPublic FDA data

Diovan

Product NDC
67544-404
11-digit product format
675440404
Labeler code
67544
Product ID
67544-404_948ffea7-be2c-4b21-9880-8e27af9a4090
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA021283
Marketing category
NDA
Marketing start
2001-07-01
Marketing end
0000-00-00
Substance
VALSARTAN
Active strength
160 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
692a3434-fece-49c6-9b7d-ed7aefc52b50Product name320260317
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
e7dfdaab-7cf9-4f89-804c-eff5108d94d1Product name920250305
b6abae2f-ee27-47bc-b150-54dc8d969483Product name220250221
52311e76-a520-4bd2-9d5b-e0b6d6f44519Product name220231208
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67544-404-302020-01-31C16284748780-19d75b9cf-f7fd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Diovan safely and effectively. See full prescribing information for Diovan. Diovan (valsartan) Tablets Initial U.S. Approval: 1996
67544-404-792020-01-31C16284748780-19d75b9cf-f7fd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Diovan safely and effectively. See full prescribing information for Diovan. Diovan (valsartan) Tablets Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-404-30Diovan30 in 1 BOTTLE, PLASTICTABLET302
67544-404-79Diovan6030 in 1 BOTTLE, PLASTICTABLET60302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-404-30EA - Each67544-40414c25e71-6664-4bba-bb34-c95c4cc61a1712014-02-04
67544-404-79EA - Each67544-404c8ee86e7-84eb-45a6-9adf-607bdc712c7a12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALSARTANACTIVE INGREDIENT80M03YXJ7IDIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
VALSARTANACTIVE MOIETY80M03YXJ7IDIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BDIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-404DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 2 package rows20140509_c6488119-6547-4abd-bc15-a809b6107d4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351762Diovan 160 MG Oral TabletPSNc6488119-6547-4abd-bc15-a809b6107d4f2
351761Diovan 80 MG Oral TabletPSNc6488119-6547-4abd-bc15-a809b6107d4f2
349201valsartan 160 MG Oral TabletPSNc6488119-6547-4abd-bc15-a809b6107d4f2
349199valsartan 80 MG Oral TabletPSNc6488119-6547-4abd-bc15-a809b6107d4f2
351762valsartan 160 MG Oral Tablet [Diovan]SBDc6488119-6547-4abd-bc15-a809b6107d4f2
351761valsartan 80 MG Oral Tablet [Diovan]SBDc6488119-6547-4abd-bc15-a809b6107d4f2
349201valsartan 160 MG Oral TabletSCDc6488119-6547-4abd-bc15-a809b6107d4f2
349199valsartan 80 MG Oral TabletSCDc6488119-6547-4abd-bc15-a809b6107d4f2
351762Diovan 160 MG Oral TabletSYc6488119-6547-4abd-bc15-a809b6107d4f2
351761Diovan 80 MG Oral TabletSYc6488119-6547-4abd-bc15-a809b6107d4f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67544-404-306754404043030 in 1 BOTTLE, PLASTICHistorical
67544-404-79675440404796030 in 1 BOTTLE, PLASTICHistorical