Valsartan

Product NDC
65162-837
11-digit product format
651620837
Labeler code
65162
Product ID
65162-837_ce6ac5f2-be9c-461a-b749-5a2e24552878
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA204011
Marketing category
ANDA
Marketing start
2016-01-27
Substance
VALSARTAN
Active strength
40 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
VALSARTAN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80M03YXJ7I
Rxcui349199, 349200, 349201, 349483

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
65162-837-03Valsartan30 in 1 BOTTLETABLET3022
65162-837-06Valsartan60 in 1 BOTTLETABLET6022
65162-837-50Valsartan500 in 1 BOTTLETABLET50022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-837-03EA - Each65162-837cd2927bd-0df8-49dd-ac81-9c7f19b1aefc12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-837VALSARTAN TABLET [AMNEAL PHARMACEUTICALS LLC]22Current NDC, Legacy NDC, 3 package rows20241031_f4a5df78-157b-4996-845c-235234250f11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349201valsartan 160 MG Oral TabletPSNf4a5df78-157b-4996-845c-235234250f1122
349200valsartan 320 MG Oral TabletPSNf4a5df78-157b-4996-845c-235234250f1122
349483valsartan 40 MG Oral TabletPSNf4a5df78-157b-4996-845c-235234250f1122
349199valsartan 80 MG Oral TabletPSNf4a5df78-157b-4996-845c-235234250f1122
349201valsartan 160 MG Oral TabletSCDf4a5df78-157b-4996-845c-235234250f1122
349200valsartan 320 MG Oral TabletSCDf4a5df78-157b-4996-845c-235234250f1122
349483valsartan 40 MG Oral TabletSCDf4a5df78-157b-4996-845c-235234250f1122
349199valsartan 80 MG Oral TabletSCDf4a5df78-157b-4996-845c-235234250f1122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-837-036516208370330 TABLET in 1 BOTTLE (65162-837-03) 30 tablet2016-01-270000-00-00NoNoCurrent
65162-837-066516208370660 TABLET in 1 BOTTLE (65162-837-06) 60 tablet2016-01-270000-00-00NoNoCurrent
65162-837-5065162083750500 TABLET in 1 BOTTLE (65162-837-50) 500 tablet2016-01-270000-00-00NoNoCurrent