FDA.reportPublic FDA data

Valsartan

Product NDC
71335-0475
11-digit product format
713350475
Labeler code
71335
Product ID
71335-0475_8b920e31-851f-496a-a423-b314538da58a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-0475-1Valsartan30 in 1 BOTTLETABLET306
71335-0475-2Valsartan90 in 1 BOTTLETABLET906
71335-0475-3Valsartan28 in 1 BOTTLETABLET286

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0475-1EA - Each71335-04758ea98d37-e9f4-46c4-9e3c-17d133b40b3a12018-03-08
71335-0475-2EA - Each71335-04751216eedf-ef24-4a70-b75d-4ff91e41510712018-03-08
71335-0475-3EA - Each71335-0475c570afbd-e0ff-4362-ae57-04a39390af7112018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0475VALSARTAN TABLET [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 3 package rows20240117_d9a16816-d4de-401a-8413-7233f4e541f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349200valsartan 320 MG Oral TabletPSNd9a16816-d4de-401a-8413-7233f4e541f86
349200valsartan 320 MG Oral TabletSCDd9a16816-d4de-401a-8413-7233f4e541f86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0475-17133504750130 TABLET in 1 BOTTLE (71335-0475-1) 30 tablet2022-01-200000-00-00NoNoCurrent
71335-0475-27133504750290 TABLET in 1 BOTTLE (71335-0475-2) 90 tablet2022-01-200000-00-00NoNoCurrent
71335-0475-37133504750328 TABLET in 1 BOTTLE (71335-0475-3) 28 tablet2022-01-200000-00-00NoNoCurrent