FDA.reportPublic FDA data

Valsartan

Product NDC
53746-840
11-digit product format
537460840
Labeler code
53746
Product ID
53746-840_254b9473-bbcb-4780-a182-ba287b886a47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA204011
Marketing category
ANDA
Marketing start
2022-10-10
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
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
53746-840-05Valsartan500 in 1 BOTTLETABLET50021
53746-840-10Valsartan1000 in 1 BOTTLETABLET100021
53746-840-90Valsartan90 in 1 BOTTLETABLET9021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-840VALSARTAN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]21Current NDC, 3 package rows20240420_f13587f8-76cb-49ad-9291-5907249d6b8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349201valsartan 160 MG Oral TabletPSNf13587f8-76cb-49ad-9291-5907249d6b8e21
349200valsartan 320 MG Oral TabletPSNf13587f8-76cb-49ad-9291-5907249d6b8e21
349483valsartan 40 MG Oral TabletPSNf13587f8-76cb-49ad-9291-5907249d6b8e21
349199valsartan 80 MG Oral TabletPSNf13587f8-76cb-49ad-9291-5907249d6b8e21
349201valsartan 160 MG Oral TabletSCDf13587f8-76cb-49ad-9291-5907249d6b8e21
349200valsartan 320 MG Oral TabletSCDf13587f8-76cb-49ad-9291-5907249d6b8e21
349483valsartan 40 MG Oral TabletSCDf13587f8-76cb-49ad-9291-5907249d6b8e21
349199valsartan 80 MG Oral TabletSCDf13587f8-76cb-49ad-9291-5907249d6b8e21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53746-840-0553746084005500 TABLET in 1 BOTTLE (53746-840-05) 500 tablet2022-10-10NoNoHistorical
53746-840-10537460840101000 TABLET in 1 BOTTLE (53746-840-10) 1000 tablet2022-10-10NoNoHistorical
53746-840-905374608409090 TABLET in 1 BOTTLE (53746-840-90) 90 tablet2022-10-10NoNoHistorical