FDA.reportPublic FDA data

Valsartan

Product NDC
62332-045
11-digit product format
623320045
Labeler code
62332
Product ID
62332-045_d9c3b1ac-bbb0-4974-b337-88e247093c72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA091367
Marketing category
ANDA
Marketing start
2016-05-20
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
62332-045-10Valsartan100 in 1 CARTONTABLET10014
62332-045-30Valsartan30 in 1 BOTTLETABLET3014
62332-045-71Valsartan500 in 1 BOTTLETABLET50014
62332-045-90Valsartan90 in 1 BOTTLETABLET9014
62332-045-91Valsartan1000 in 1 BOTTLETABLET100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-045-71EA - Each62332-045a3956cd2-ccba-4b91-a830-33e52ece95bd12016-07-19
62332-045-90EA - Each62332-04510944778-a848-411b-95a4-ab308d9fe3fc12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-045VALSARTAN TABLET [ALEMBIC PHARMACEUTICALS INC.]14Current NDC, Legacy NDC, 5 package rows20210828_8478a05f-38fd-412d-af49-69a73a787c8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349199valsartan 80 MG Oral TabletPSN9288b57c-d9e5-4274-83ea-1d3095cbc4f2100
349199valsartan 80 MG Oral TabletSCD9288b57c-d9e5-4274-83ea-1d3095cbc4f2100
349201valsartan 160 MG Oral TabletPSN8478a05f-38fd-412d-af49-69a73a787c8f14
349200valsartan 320 MG Oral TabletPSN8478a05f-38fd-412d-af49-69a73a787c8f14
349483valsartan 40 MG Oral TabletPSN8478a05f-38fd-412d-af49-69a73a787c8f14
349199valsartan 80 MG Oral TabletPSN8478a05f-38fd-412d-af49-69a73a787c8f14
349201valsartan 160 MG Oral TabletSCD8478a05f-38fd-412d-af49-69a73a787c8f14
349200valsartan 320 MG Oral TabletSCD8478a05f-38fd-412d-af49-69a73a787c8f14
349483valsartan 40 MG Oral TabletSCD8478a05f-38fd-412d-af49-69a73a787c8f14
349199valsartan 80 MG Oral TabletSCD8478a05f-38fd-412d-af49-69a73a787c8f14
349199valsartan 80 MG Oral TabletPSNb530ba58-1d58-578f-e053-2995a90adcd71
349199valsartan 80 MG Oral TabletSCDb530ba58-1d58-578f-e053-2995a90adcd71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-045-1062332004510100 TABLET in 1 CARTON (62332-045-10) 100 tablet2016-05-200000-00-00NoNoCurrent
62332-045-306233200453030 TABLET in 1 BOTTLE (62332-045-30) 30 tablet2016-05-200000-00-00NoNoCurrent
62332-045-7162332004571500 TABLET in 1 BOTTLE (62332-045-71) 500 tablet2016-05-200000-00-00NoNoCurrent
62332-045-906233200459090 TABLET in 1 BOTTLE (62332-045-90) 90 tablet2016-05-200000-00-00NoNoCurrent
62332-045-91623320045911000 TABLET in 1 BOTTLE (62332-045-91) 1000 tablet2016-05-200000-00-00NoNoCurrent