FDA.reportPublic FDA data

valsartan

Product NDC
50090-5191
11-digit product format
500905191
Labeler code
50090
Product ID
50090-5191_b4e28e8f-ba4c-4da2-aa39-4d20365fa101
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203536
Marketing category
ANDA
Marketing start
2015-01-05
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALSARTAN160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80M03YXJ7I
Rxcui349201

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
50090-5191-02023-02-07C16284748780-1f386c649-ff7d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996
50090-5191-12023-02-07C16284748780-1f386c649-ff7d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996
50090-5191-02023-01-30C16284748780-1f386c649-ff7d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996
50090-5191-12023-01-30C16284748780-1f386c649-ff7d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5191-0valsartan30 in 1 BOTTLETABLET305
50090-5191-1valsartan90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5191-0EA - Each50090-519182b6f1bf-c0b8-4e63-acd7-42e1921e163512023-04-07
50090-5191-1EA - Each50090-5191446ad623-7e45-472e-b46b-538c40b82c6f12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5191VALSARTAN (VALSARTAN) TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20230208_e352db8b-0485-492a-8734-0a415566d764.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349201valsartan 160 MG Oral TabletPSNe352db8b-0485-492a-8734-0a415566d7645
349201valsartan 160 MG Oral TabletSCDe352db8b-0485-492a-8734-0a415566d7645

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5191-05009051910030 TABLET in 1 BOTTLE (50090-5191-0) 30 tablet2020-09-290000-00-00NoNoCurrent
50090-5191-15009051910190 TABLET in 1 BOTTLE (50090-5191-1) 90 tablet2020-09-290000-00-00NoNoCurrent