FDA.reportPublic FDA data

Valsartan

Product NDC
50268-747
11-digit product format
502680747
Labeler code
50268
Product ID
50268-747_2b4bed38-a3f8-00ef-e063-6394a90afba8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA203311
Marketing category
ANDA
Marketing start
2023-10-24
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-747-11Valsartan1 in 1 BLISTER PACKTABLET, FILM COATED12
50268-747-15Valsartan50 in 1 BOXTABLET, FILM COATED502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-747-11EA - Each50268-7474cc122b4-dfee-45aa-a695-b4ca03bbf36412023-12-05
50268-747-15EA - Each50268-7473a61c92e-0bf6-43b2-abc3-3666ca3a2d1a12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-747VALSARTAN TABLET, FILM COATED [AVPAK]2Current NDC, 2 package rows20250112_0878f27e-5368-c93f-e063-6394a90a1086.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349201valsartan 160 MG Oral TabletPSN0878f27e-5368-c93f-e063-6394a90a10862
349200valsartan 320 MG Oral TabletPSN0878f27e-5368-c93f-e063-6394a90a10862
349483valsartan 40 MG Oral TabletPSN0878f27e-5368-c93f-e063-6394a90a10862
349199valsartan 80 MG Oral TabletPSN0878f27e-5368-c93f-e063-6394a90a10862
349201valsartan 160 MG Oral TabletSCD0878f27e-5368-c93f-e063-6394a90a10862
349200valsartan 320 MG Oral TabletSCD0878f27e-5368-c93f-e063-6394a90a10862
349483valsartan 40 MG Oral TabletSCD0878f27e-5368-c93f-e063-6394a90a10862
349199valsartan 80 MG Oral TabletSCD0878f27e-5368-c93f-e063-6394a90a10862

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-747-11502680747111 in 1 BLISTER PACKHistorical
50268-747-155026807471550 BLISTER PACK in 1 BOX (50268-747-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-747-11) 50 blister pack2023-10-24NoNoHistorical