Valsartan

Product NDC
33342-063
11-digit product format
333420063
Labeler code
33342
Product ID
33342-063_1fff1472-c659-469c-8786-f3c9b6689524
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA202696
Marketing category
ANDA
Marketing start
2016-09-19
Substance
VALSARTAN
Active strength
80 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
VALSARTAN80 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
33342-063-10Valsartan90 in 1 BOTTLETABLET, FILM COATED908
33342-063-44Valsartan1000 in 1 BOTTLETABLET, FILM COATED10008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-063VALSARTAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]8Current NDC, Legacy NDC, 2 package rows20221002_251ccff4-bf86-453b-9d1c-e3c1ecfd3a46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349201valsartan 160 MG Oral TabletPSN251ccff4-bf86-453b-9d1c-e3c1ecfd3a468
349200valsartan 320 MG Oral TabletPSN251ccff4-bf86-453b-9d1c-e3c1ecfd3a468
349483valsartan 40 MG Oral TabletPSN251ccff4-bf86-453b-9d1c-e3c1ecfd3a468
349199valsartan 80 MG Oral TabletPSN251ccff4-bf86-453b-9d1c-e3c1ecfd3a468
349201valsartan 160 MG Oral TabletSCD251ccff4-bf86-453b-9d1c-e3c1ecfd3a468
349200valsartan 320 MG Oral TabletSCD251ccff4-bf86-453b-9d1c-e3c1ecfd3a468
349483valsartan 40 MG Oral TabletSCD251ccff4-bf86-453b-9d1c-e3c1ecfd3a468
349199valsartan 80 MG Oral TabletSCD251ccff4-bf86-453b-9d1c-e3c1ecfd3a468
349199valsartan 80 MG Oral TabletPSNb4c69771-fc62-4274-a57b-8f6f2407a7ea3
349199valsartan 80 MG Oral TabletSCDb4c69771-fc62-4274-a57b-8f6f2407a7ea3
349199valsartan 80 MG Oral TabletPSN946692f5-0fe2-89b7-e053-2995a90a4d912
349199valsartan 80 MG Oral TabletSCD946692f5-0fe2-89b7-e053-2995a90a4d912
349199valsartan 80 MG Oral TabletPSN94658ed5-cb3b-7b19-e053-2a95a90a63fc1
349199valsartan 80 MG Oral TabletPSN946712b3-9c45-58fa-e053-2a95a90a98181
349199valsartan 80 MG Oral TabletSCD94658ed5-cb3b-7b19-e053-2a95a90a63fc1
349199valsartan 80 MG Oral TabletSCD946712b3-9c45-58fa-e053-2a95a90a98181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
33342-063-103334200631090 TABLET, FILM COATED in 1 BOTTLE (33342-063-10) 2016-09-190000-00-00NoNoCurrent
33342-063-44333420063441000 TABLET, FILM COATED in 1 BOTTLE (33342-063-44) 2016-09-190000-00-00NoNoCurrent