Valsartan

Product NDC
10135-769
11-digit product format
101350769
Labeler code
10135
Product ID
10135-769_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
80 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-769-90Valsartan90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-769VALSARTAN 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
10135-769-901013507699090 TABLET in 1 BOTTLE (10135-769-90) 90 tablet2022-12-010000-00-00NoNoCurrent