FDA.reportPublic FDA data

Valsartan

Product NDC
42385-991
11-digit product format
423850991
Labeler code
42385
Product ID
42385-991_6e1f63ad-e554-421b-a699-4e8c9bd4d239
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Laurus Labs Limited
Application
ANDA218897
Marketing category
ANDA
Marketing start
2026-04-22
Substance
VALSARTAN
Active strength
160 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Valsartan
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALSARTAN160 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
42385-991-05Valsartan500 in 1 BOTTLETABLET, FILM COATED5001
42385-991-10Valsartan10 in 1 BLISTER PACKTABLET, FILM COATED101
42385-991-30Valsartan30 in 1 BOTTLETABLET, FILM COATED301
42385-991-68Valsartan10 in 1 CARTONTABLET, FILM COATED101
42385-991-90Valsartan90 in 1 BOTTLETABLET, FILM COATED901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349201valsartan 160 MG Oral TabletPSN6e1f63ad-e554-421b-a699-4e8c9bd4d2391
349200valsartan 320 MG Oral TabletPSN6e1f63ad-e554-421b-a699-4e8c9bd4d2391
349483valsartan 40 MG Oral TabletPSN6e1f63ad-e554-421b-a699-4e8c9bd4d2391
349199valsartan 80 MG Oral TabletPSN6e1f63ad-e554-421b-a699-4e8c9bd4d2391
349201valsartan 160 MG Oral TabletSCD6e1f63ad-e554-421b-a699-4e8c9bd4d2391
349200valsartan 320 MG Oral TabletSCD6e1f63ad-e554-421b-a699-4e8c9bd4d2391
349483valsartan 40 MG Oral TabletSCD6e1f63ad-e554-421b-a699-4e8c9bd4d2391
349199valsartan 80 MG Oral TabletSCD6e1f63ad-e554-421b-a699-4e8c9bd4d2391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42385-991-0542385099105500 TABLET, FILM COATED in 1 BOTTLE (42385-991-05) 2026-04-22NoNoHistorical
42385-991-104238509911010 in 1 BLISTER PACKHistorical
42385-991-304238509913030 TABLET, FILM COATED in 1 BOTTLE (42385-991-30) 2026-04-22NoNoHistorical
42385-991-684238509916810 BLISTER PACK in 1 CARTON (42385-991-68) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-991-10) 10 blister pack2026-04-22NoNoHistorical
42385-991-904238509919090 TABLET, FILM COATED in 1 BOTTLE (42385-991-90) 2026-04-22NoNoHistorical