FDA.reportPublic FDA data

Valsartan

Product NDC
50090-6346
11-digit product format
500906346
Labeler code
50090
Product ID
50090-6346_35890fc6-a455-41c4-82a5-3a8b9e9094c0
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
320 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Valsartan
Listing expiration
2027-12-31

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6346-0Valsartan30 in 1 BOTTLETABLET, FILM COATED305
50090-6346-1Valsartan90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6346-0EA - Each50090-634689a84d51-ec21-4915-95f0-d9c543c9e74e12023-03-13
50090-6346-1EA - Each50090-63466a87b03c-670d-4dec-a05d-c626b1bbc99d12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6346VALSARTAN (VALSARTAN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20230203_0925a24f-6a72-4c77-b4e6-0a8f5b12c8d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349200valsartan 320 MG Oral TabletPSN0925a24f-6a72-4c77-b4e6-0a8f5b12c8d05
349200valsartan 320 MG Oral TabletSCD0925a24f-6a72-4c77-b4e6-0a8f5b12c8d05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6346-05009063460030 TABLET, FILM COATED in 1 BOTTLE (50090-6346-0) 2023-01-25NoNoHistorical
50090-6346-15009063460190 TABLET, FILM COATED in 1 BOTTLE (50090-6346-1) 2023-01-25NoNoHistorical