FDA.reportPublic FDA data

Valsartan

Product NDC
71335-2155
11-digit product format
713352155
Labeler code
71335
Product ID
71335-2155_08e219cd-0de6-49ba-a526-e02307e5f437
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203311
Marketing category
ANDA
Marketing start
2021-06-23
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
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2155-1Valsartan30 in 1 BOTTLETABLET, FILM COATED30101
71335-2155-2Valsartan90 in 1 BOTTLETABLET, FILM COATED90101
71335-2155-3Valsartan28 in 1 BOTTLETABLET, FILM COATED28101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2155VALSARTAN (VALSARTAN) TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 3 package rows20231123_c12db287-786c-47ae-a1f3-df04ddfd2a70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349200valsartan 320 MG Oral TabletPSNc12db287-786c-47ae-a1f3-df04ddfd2a70101
349200valsartan 320 MG Oral TabletSCDc12db287-786c-47ae-a1f3-df04ddfd2a70101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2155-17133521550130 TABLET, FILM COATED in 1 BOTTLE (71335-2155-1) 2022-08-220000-00-00NoNoCurrent
71335-2155-27133521550290 TABLET, FILM COATED in 1 BOTTLE (71335-2155-2) 2022-08-220000-00-00NoNoCurrent
71335-2155-37133521550328 TABLET, FILM COATED in 1 BOTTLE (71335-2155-3) 2022-08-220000-00-00NoNoCurrent