FDA.reportPublic FDA data

Valsartan

Product NDC
63187-655
11-digit product format
631870655
Labeler code
63187
Product ID
63187-655_0e31e187-683b-437f-91b6-d14cd11882bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204821
Marketing category
ANDA
Marketing start
2015-08-31
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
Valsartan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALSARTAN320 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80M03YXJ7I
Rxcui349200

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-655-30Valsartan30 in 1 BOTTLETABLET303
63187-655-60Valsartan60 in 1 BOTTLETABLET603
63187-655-90Valsartan90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-655VALSARTAN TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20210113_b58471fe-e2c6-4cc5-9d49-6a3111f6e002.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349200valsartan 320 MG Oral TabletPSNb58471fe-e2c6-4cc5-9d49-6a3111f6e0023
349200valsartan 320 MG Oral TabletSCDb58471fe-e2c6-4cc5-9d49-6a3111f6e0023

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-655-306318706553030 TABLET in 1 BOTTLE (63187-655-30) 30 tablet2018-12-010000-00-00NoNoCurrent
63187-655-606318706556060 TABLET in 1 BOTTLE (63187-655-60) 60 tablet2018-12-010000-00-00NoNoCurrent
63187-655-906318706559090 TABLET in 1 BOTTLE (63187-655-90) 90 tablet2018-12-010000-00-00NoNoCurrent