FDA.reportPublic FDA data

Valsartan

Product NDC
50090-6348
11-digit product format
500906348
Labeler code
50090
Product ID
50090-6348_a4548b54-9d64-45e5-a257-817ffcb85c25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203311
Marketing category
ANDA
Marketing start
2021-06-23
Substance
VALSARTAN
Active strength
160 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
VALSARTAN160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80M03YXJ7I
Rxcui349201

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
50090-6348-0Valsartan30 in 1 BOTTLETABLET, FILM COATED303
50090-6348-1Valsartan90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6348-0EA - Each50090-63483fdd390d-97da-453f-bac1-ed4f21cf6fa112023-03-13
50090-6348-1EA - Each50090-6348c7d673e6-6a96-47f0-b5c5-eb591005bdd612023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6348VALSARTAN (VALSARTAN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Current NDC, 2 package rows20231004_688b5c82-2eba-445c-869e-60609f5db86a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349201valsartan 160 MG Oral TabletPSN688b5c82-2eba-445c-869e-60609f5db86a3
349201valsartan 160 MG Oral TabletSCD688b5c82-2eba-445c-869e-60609f5db86a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6348-05009063480030 TABLET, FILM COATED in 1 BOTTLE (50090-6348-0) 2023-01-26NoNoCurrent
50090-6348-15009063480190 TABLET, FILM COATED in 1 BOTTLE (50090-6348-1) 2023-01-26NoNoCurrent