FDA.reportPublic FDA data

Valsartan

Product NDC
10135-768
11-digit product format
101350768
Labeler code
10135
Product ID
10135-768_efcc5f0c-4eb2-8d75-e053-2995a90a932c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc.
Application
ANDA205347
Marketing category
ANDA
Marketing start
2022-12-01
Marketing end
0000-00-00
Substance
VALSARTAN
Active strength
40 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-768-302025-01-30C16284748780-12cef2736-a479-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval:1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-768-30Valsartan30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-768-30EA - Each10135-768bf65531d-179f-44bd-90ba-b8a4cd179b0412023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-768VALSARTAN TABLET [MARLEX PHARMACEUTICALS, INC.]2Legacy NDC, 1 package rows20230708_efcc5d9e-e8d8-2da3-e053-2a95a90ac3d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349201valsartan 160 MG Oral TabletPSNefcc5d9e-e8d8-2da3-e053-2a95a90ac3d92
349200valsartan 320 MG Oral TabletPSNefcc5d9e-e8d8-2da3-e053-2a95a90ac3d92
349483valsartan 40 MG Oral TabletPSNefcc5d9e-e8d8-2da3-e053-2a95a90ac3d92
349199valsartan 80 MG Oral TabletPSNefcc5d9e-e8d8-2da3-e053-2a95a90ac3d92
349201valsartan 160 MG Oral TabletSCDefcc5d9e-e8d8-2da3-e053-2a95a90ac3d92
349200valsartan 320 MG Oral TabletSCDefcc5d9e-e8d8-2da3-e053-2a95a90ac3d92
349483valsartan 40 MG Oral TabletSCDefcc5d9e-e8d8-2da3-e053-2a95a90ac3d92
349199valsartan 80 MG Oral TabletSCDefcc5d9e-e8d8-2da3-e053-2a95a90ac3d92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-768-301013507683030 TABLET in 1 BOTTLE (10135-768-30) 30 tablet2022-12-010000-00-00NoNoCurrent