FDA.reportPublic FDA data

Valsartan

Product NDC
55111-731
11-digit product format
551110731
Labeler code
55111
Product ID
55111-731_f7d1bd41-da10-005a-6e30-8a816db87867
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA201618
Marketing category
ANDA
Marketing start
2018-03-30
Substance
VALSARTAN
Active strength
40 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
VALSARTAN40 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
55111-731-01Valsartan100 in 1 BOTTLETABLET, FILM COATED10019
55111-731-05Valsartan500 in 1 BOTTLETABLET, FILM COATED50019
55111-731-30Valsartan30 in 1 BOTTLETABLET, FILM COATED3019
55111-731-60Valsartan60 in 1 BOTTLETABLET, FILM COATED6019
55111-731-78Valsartan10 in 1 CARTONTABLET, FILM COATED1019
55111-731-79Valsartan10 in 1 BLISTER PACKTABLET, FILM COATED1019
55111-731-90Valsartan90 in 1 BOTTLETABLET, FILM COATED9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-731-30EA - Each55111-731eb6d11a4-e9eb-4e73-9db3-43731aac0d6112022-01-06
55111-731-90EA - Each55111-731623b58b6-375b-4ac4-94db-388edec2435f12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-731VALSARTAN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]18Current NDC, Legacy NDC, 7 package rows20221203_75235313-8a07-8849-9b5a-12887992033e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349201valsartan 160 MG Oral TabletPSN75235313-8a07-8849-9b5a-12887992033e19
349200valsartan 320 MG Oral TabletPSN75235313-8a07-8849-9b5a-12887992033e19
349483valsartan 40 MG Oral TabletPSN75235313-8a07-8849-9b5a-12887992033e19
349199valsartan 80 MG Oral TabletPSN75235313-8a07-8849-9b5a-12887992033e19
349201valsartan 160 MG Oral TabletSCD75235313-8a07-8849-9b5a-12887992033e19
349200valsartan 320 MG Oral TabletSCD75235313-8a07-8849-9b5a-12887992033e19
349483valsartan 40 MG Oral TabletSCD75235313-8a07-8849-9b5a-12887992033e19
349199valsartan 80 MG Oral TabletSCD75235313-8a07-8849-9b5a-12887992033e19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-731-0155111073101100 TABLET, FILM COATED in 1 BOTTLE (55111-731-01) 2021-10-050000-00-00NoNoCurrent
55111-731-0555111073105500 TABLET, FILM COATED in 1 BOTTLE (55111-731-05) 2021-10-050000-00-00NoNoCurrent
55111-731-305511107313030 TABLET, FILM COATED in 1 BOTTLE (55111-731-30) 2021-10-050000-00-00NoNoCurrent
55111-731-605511107316060 TABLET, FILM COATED in 1 BOTTLE (55111-731-60) 2021-10-050000-00-00NoNoCurrent
55111-731-785511107317810 BLISTER PACK in 1 CARTON (55111-731-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-731-79) 10 blister pack2021-10-050000-00-00NoNoCurrent
55111-731-795511107317910 in 1 BLISTER PACKHistorical
55111-731-905511107319090 TABLET, FILM COATED in 1 BOTTLE (55111-731-90) 2021-10-052026-05-31NoNoCurrent