FDA.reportPublic FDA data

Valsartan

Product NDC
67877-418
11-digit product format
678770418
Labeler code
67877
Product ID
67877-418_b24a6cf6-a1b4-4d30-8a87-ec5ad793de42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA205536
Marketing category
ANDA
Marketing start
2019-03-14
Substance
VALSARTAN
Active strength
320 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
VALSARTAN320 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
67877-418-05Valsartan500 in 1 BOTTLETABLET, FILM COATED50014
67877-418-10Valsartan1000 in 1 BOTTLETABLET, FILM COATED100014
67877-418-90Valsartan90 in 1 BOTTLETABLET, FILM COATED9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-418-90EA - Each67877-418809641bd-d482-49c4-8b95-c47016eb04ef12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-418VALSARTAN TABLET, FILM COATED [ASCEND LABORATORIES, LLC]13Current NDC, Legacy NDC, 3 package rows20220506_7b4ecaf9-e84c-4660-9cd1-65a238efd8a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349201valsartan 160 MG Oral TabletPSN7b4ecaf9-e84c-4660-9cd1-65a238efd8a814
349200valsartan 320 MG Oral TabletPSN7b4ecaf9-e84c-4660-9cd1-65a238efd8a814
349483valsartan 40 MG Oral TabletPSN7b4ecaf9-e84c-4660-9cd1-65a238efd8a814
349199valsartan 80 MG Oral TabletPSN7b4ecaf9-e84c-4660-9cd1-65a238efd8a814
349201valsartan 160 MG Oral TabletSCD7b4ecaf9-e84c-4660-9cd1-65a238efd8a814
349200valsartan 320 MG Oral TabletSCD7b4ecaf9-e84c-4660-9cd1-65a238efd8a814
349483valsartan 40 MG Oral TabletSCD7b4ecaf9-e84c-4660-9cd1-65a238efd8a814
349199valsartan 80 MG Oral TabletSCD7b4ecaf9-e84c-4660-9cd1-65a238efd8a814
349200valsartan 320 MG Oral TabletPSN34dade80-c1df-44f9-86ab-16bb110a1a572
349200valsartan 320 MG Oral TabletSCD34dade80-c1df-44f9-86ab-16bb110a1a572

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-418-0567877041805500 TABLET, FILM COATED in 1 BOTTLE (67877-418-05) 2019-03-140000-00-00NoNoCurrent
67877-418-10678770418101000 TABLET, FILM COATED in 1 BOTTLE (67877-418-10) 2019-03-140000-00-00NoNoCurrent
67877-418-906787704189090 TABLET, FILM COATED in 1 BOTTLE (67877-418-90) 2019-03-140000-00-00NoNoCurrent