FDA.reportPublic FDA data

Valsartan

Product NDC
71205-301
11-digit product format
712050301
Labeler code
71205
Product ID
71205-301_a3825354-7356-4e03-880f-d510a9019748
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202696
Marketing category
ANDA
Marketing start
2016-09-19
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
Rxcui349200

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
71205-301-30Valsartan30 in 1 BOTTLETABLET, FILM COATED303
71205-301-60Valsartan60 in 1 BOTTLETABLET, FILM COATED603
71205-301-90Valsartan90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-301-90EA - Each71205-3017b4e9ada-b8f0-4e3a-a271-491e4fe2f70812019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-301VALSARTAN TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20221110_fadb25bb-acd9-4aaf-971c-82259b739e5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349200valsartan 320 MG Oral TabletPSNfadb25bb-acd9-4aaf-971c-82259b739e5b3
349200valsartan 320 MG Oral TabletSCDfadb25bb-acd9-4aaf-971c-82259b739e5b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-301-307120503013030 TABLET, FILM COATED in 1 BOTTLE (71205-301-30) 2019-08-010000-00-00NoNoCurrent
71205-301-607120503016060 TABLET, FILM COATED in 1 BOTTLE (71205-301-60) 2019-08-010000-00-00NoNoCurrent
71205-301-907120503019090 TABLET, FILM COATED in 1 BOTTLE (71205-301-90) 2019-08-010000-00-00NoNoCurrent