FDA.reportPublic FDA data

VALSARTAN

Product NDC
72189-049
11-digit product format
721890049
Labeler code
72189
Product ID
72189-049_2cb5d72e-fb6b-b51b-e063-6294a90a7c75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VALSARTAN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA202696
Marketing category
ANDA
Marketing start
2019-10-08
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

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
72189-049-602025-01-28C16284748780-1f386c649-c41a-0266-e053-dadaa90a7c1aVALSARTAN
72189-049-302023-01-30C16284748780-1f386c649-fce7-0266-e053-dadaa90a7c1aVALSARTAN
72189-049-602023-01-30C16284748780-1f386c649-c41a-0266-e053-dadaa90a7c1aVALSARTAN
72189-049-902023-01-30C16284748780-1f386c649-f0b3-0266-e053-dadaa90a7c1aVALSARTAN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-049-60VALSARTAN60 in 1 BOTTLETABLET, FILM COATED602
72189-049-30VALSARTAN30 in 1 BOTTLETABLET, FILM COATED301
72189-049-90VALSARTAN90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-049-30EA - Each72189-049273def35-4db0-46c5-94e9-1ae198b0487112019-11-12
72189-049-60EA - Each72189-049f9eebc26-c35e-413e-b030-2f518de9765812019-11-12
72189-049-90EA - Each72189-049917b9a53-415d-4546-80c1-acbc97ccd82612019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-049VALSARTAN TABLET, FILM COATED [DIRECT_RX]2Current NDC, Legacy NDC, 1 package rows20250130_946692f5-0fe2-89b7-e053-2995a90a4d91.zip
72189-049VALSARTAN TABLET, FILM COATED [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20191009_94658ed5-cb3b-7b19-e053-2a95a90a63fc.zip
72189-049VALSARTAN TABLET, FILM COATED [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20191009_946712b3-9c45-58fa-e053-2a95a90a9818.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
72189-049-307218900493030 TABLET, FILM COATED in 1 BOTTLE (72189-049-30) 2019-10-080000-00-00NoNoCurrent
72189-049-607218900496060 TABLET, FILM COATED in 1 BOTTLE (72189-049-60) 2019-10-080000-00-00NoNoCurrent
72189-049-907218900499090 TABLET, FILM COATED in 1 BOTTLE (72189-049-90) 2019-10-080000-00-00NoNoCurrent