FDA.reportPublic FDA data

Diovan

Product NDC
0078-0360
11-digit product format
000780360
Labeler code
0078
Product ID
0078-0360_bb542e5b-0b85-45db-8542-e203b9cd8618
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA021283
Marketing category
NDA
Marketing start
2001-07-01
Substance
VALSARTAN
Active strength
320 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diovan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALSARTAN320 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80M03YXJ7I
Rxcui349199, 349200, 349201, 349483, 351761, 351762, 352001, 352274

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0360-34Diovan90 in 1 BOTTLETABLET9031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0360-11EA - Each0078-03607f0c3161-f11a-43c2-923f-3afe5ddb2c6e12012-07-24
0078-0360-34EA - Each0078-036061baa5f9-eb73-4914-870d-f1213e3f452a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALSARTANACTIVE INGREDIENT80M03YXJ7IDIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]15
VALSARTANACTIVE MOIETY80M03YXJ7IDIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]15
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]15
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]15
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]15
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]15
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BDIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]15
VALSARTANACTIVE INGREDIENT80M03YXJ7IDIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]3
VALSARTANACTIVE MOIETY80M03YXJ7IDIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]3
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BDIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]3
VALSARTANACTIVE INGREDIENT80M03YXJ7IDIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]1
VALSARTANACTIVE MOIETY80M03YXJ7IDIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BDIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0360DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]29Current NDC, Legacy NDC, 1 package rows20250110_5ddba454-f3e6-43c2-a7a6-58365d297213.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351762Diovan 160 MG Oral TabletPSN5ddba454-f3e6-43c2-a7a6-58365d29721331
352001Diovan 320 MG Oral TabletPSN5ddba454-f3e6-43c2-a7a6-58365d29721331
352274Diovan 40 MG Oral TabletPSN5ddba454-f3e6-43c2-a7a6-58365d29721331
351761Diovan 80 MG Oral TabletPSN5ddba454-f3e6-43c2-a7a6-58365d29721331
349201valsartan 160 MG Oral TabletPSN5ddba454-f3e6-43c2-a7a6-58365d29721331
349200valsartan 320 MG Oral TabletPSN5ddba454-f3e6-43c2-a7a6-58365d29721331
349483valsartan 40 MG Oral TabletPSN5ddba454-f3e6-43c2-a7a6-58365d29721331
349199valsartan 80 MG Oral TabletPSN5ddba454-f3e6-43c2-a7a6-58365d29721331
351762valsartan 160 MG Oral Tablet [Diovan]SBD5ddba454-f3e6-43c2-a7a6-58365d29721331
352001valsartan 320 MG Oral Tablet [Diovan]SBD5ddba454-f3e6-43c2-a7a6-58365d29721331
352274valsartan 40 MG Oral Tablet [Diovan]SBD5ddba454-f3e6-43c2-a7a6-58365d29721331
351761valsartan 80 MG Oral Tablet [Diovan]SBD5ddba454-f3e6-43c2-a7a6-58365d29721331
349201valsartan 160 MG Oral TabletSCD5ddba454-f3e6-43c2-a7a6-58365d29721331
349200valsartan 320 MG Oral TabletSCD5ddba454-f3e6-43c2-a7a6-58365d29721331
349483valsartan 40 MG Oral TabletSCD5ddba454-f3e6-43c2-a7a6-58365d29721331
349199valsartan 80 MG Oral TabletSCD5ddba454-f3e6-43c2-a7a6-58365d29721331
351762Diovan 160 MG Oral TabletSY5ddba454-f3e6-43c2-a7a6-58365d29721331
352001Diovan 320 MG Oral TabletSY5ddba454-f3e6-43c2-a7a6-58365d29721331
352274Diovan 40 MG Oral TabletSY5ddba454-f3e6-43c2-a7a6-58365d29721331
351761Diovan 80 MG Oral TabletSY5ddba454-f3e6-43c2-a7a6-58365d29721331
351762Diovan 160 MG Oral TabletPSNe80642ad-bb06-4546-ae33-5bc70cf05cee3
352001Diovan 320 MG Oral TabletPSNe80642ad-bb06-4546-ae33-5bc70cf05cee3
352274Diovan 40 MG Oral TabletPSNe80642ad-bb06-4546-ae33-5bc70cf05cee3
351761Diovan 80 MG Oral TabletPSNe80642ad-bb06-4546-ae33-5bc70cf05cee3
349201valsartan 160 MG Oral TabletPSNe80642ad-bb06-4546-ae33-5bc70cf05cee3
349200valsartan 320 MG Oral TabletPSNe80642ad-bb06-4546-ae33-5bc70cf05cee3
349483valsartan 40 MG Oral TabletPSNe80642ad-bb06-4546-ae33-5bc70cf05cee3
349199valsartan 80 MG Oral TabletPSNe80642ad-bb06-4546-ae33-5bc70cf05cee3
351762valsartan 160 MG Oral Tablet [Diovan]SBDe80642ad-bb06-4546-ae33-5bc70cf05cee3
352001valsartan 320 MG Oral Tablet [Diovan]SBDe80642ad-bb06-4546-ae33-5bc70cf05cee3
352274valsartan 40 MG Oral Tablet [Diovan]SBDe80642ad-bb06-4546-ae33-5bc70cf05cee3
351761valsartan 80 MG Oral Tablet [Diovan]SBDe80642ad-bb06-4546-ae33-5bc70cf05cee3
349201valsartan 160 MG Oral TabletSCDe80642ad-bb06-4546-ae33-5bc70cf05cee3
349200valsartan 320 MG Oral TabletSCDe80642ad-bb06-4546-ae33-5bc70cf05cee3
349483valsartan 40 MG Oral TabletSCDe80642ad-bb06-4546-ae33-5bc70cf05cee3
349199valsartan 80 MG Oral TabletSCDe80642ad-bb06-4546-ae33-5bc70cf05cee3
351762Diovan 160 MG Oral TabletSYe80642ad-bb06-4546-ae33-5bc70cf05cee3
352001Diovan 320 MG Oral TabletSYe80642ad-bb06-4546-ae33-5bc70cf05cee3
352274Diovan 40 MG Oral TabletSYe80642ad-bb06-4546-ae33-5bc70cf05cee3
351761Diovan 80 MG Oral TabletSYe80642ad-bb06-4546-ae33-5bc70cf05cee3
351762Diovan 160 MG Oral TabletPSNd73a7aa3-5b5f-4532-9936-752366a2430d1
352001Diovan 320 MG Oral TabletPSNd73a7aa3-5b5f-4532-9936-752366a2430d1
351761Diovan 80 MG Oral TabletPSNd73a7aa3-5b5f-4532-9936-752366a2430d1
349201valsartan 160 MG Oral TabletPSNd73a7aa3-5b5f-4532-9936-752366a2430d1
349200valsartan 320 MG Oral TabletPSNd73a7aa3-5b5f-4532-9936-752366a2430d1
349199valsartan 80 MG Oral TabletPSNd73a7aa3-5b5f-4532-9936-752366a2430d1
351762valsartan 160 MG Oral Tablet [Diovan]SBDd73a7aa3-5b5f-4532-9936-752366a2430d1
352001valsartan 320 MG Oral Tablet [Diovan]SBDd73a7aa3-5b5f-4532-9936-752366a2430d1
351761valsartan 80 MG Oral Tablet [Diovan]SBDd73a7aa3-5b5f-4532-9936-752366a2430d1
349201valsartan 160 MG Oral TabletSCDd73a7aa3-5b5f-4532-9936-752366a2430d1
349200valsartan 320 MG Oral TabletSCDd73a7aa3-5b5f-4532-9936-752366a2430d1
349199valsartan 80 MG Oral TabletSCDd73a7aa3-5b5f-4532-9936-752366a2430d1
351762Diovan 160 MG Oral TabletSYd73a7aa3-5b5f-4532-9936-752366a2430d1
352001Diovan 320 MG Oral TabletSYd73a7aa3-5b5f-4532-9936-752366a2430d1
351761Diovan 80 MG Oral TabletSYd73a7aa3-5b5f-4532-9936-752366a2430d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0360-340007803603490 TABLET in 1 BOTTLE (0078-0360-34) 90 tablet2001-07-010000-00-00NoNoCurrent