FDA.reportPublic FDA data

Diovan

Product NDC
68151-5044
11-digit product format
681515044
Labeler code
68151
Product ID
68151-5044_8383cbdc-fff2-4340-a496-e86a69173503
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA021283
Marketing category
NDA
Marketing start
2001-07-01
Marketing end
0000-00-00
Substance
VALSARTAN
Active strength
40 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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
68151-5044-12020-01-31C16284748780-19d75b9d0-a51c-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, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-5044-1Diovan1 in 1 PACKAGETABLET13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALSARTANACTIVE INGREDIENT80M03YXJ7IDIOVAN (VALSARTAN) TABLET [CARILION MATERIALS MANAGEMENT]2
VALSARTANACTIVE MOIETY80M03YXJ7IDIOVAN (VALSARTAN) TABLET [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIOVAN (VALSARTAN) TABLET [CARILION MATERIALS MANAGEMENT]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDIOVAN (VALSARTAN) TABLET [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDIOVAN (VALSARTAN) TABLET [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIOVAN (VALSARTAN) TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIOVAN (VALSARTAN) TABLET [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BDIOVAN (VALSARTAN) TABLET [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIOVAN (VALSARTAN) TABLET [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIOVAN (VALSARTAN) TABLET [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-5044DIOVAN (VALSARTAN) TABLET [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160806_cfdd7a0a-f8e2-4ecb-8169-bc9a8425c0a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
352274Diovan 40 MG Oral TabletPSNcfdd7a0a-f8e2-4ecb-8169-bc9a8425c0a83
349483valsartan 40 MG Oral TabletPSNcfdd7a0a-f8e2-4ecb-8169-bc9a8425c0a83
352274valsartan 40 MG Oral Tablet [Diovan]SBDcfdd7a0a-f8e2-4ecb-8169-bc9a8425c0a83
349483valsartan 40 MG Oral TabletSCDcfdd7a0a-f8e2-4ecb-8169-bc9a8425c0a83
352274Diovan 40 MG Oral TabletSYcfdd7a0a-f8e2-4ecb-8169-bc9a8425c0a83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-5044-1681515044011 in 1 PACKAGEHistorical