Valsartan

Product NDC
46708-045
11-digit product format
467080045
Labeler code
46708
Product ID
46708-045_3c6999e0-a1f1-40f0-8a6e-f3513410fd5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA091367
Marketing category
ANDA
Marketing start
2015-01-06
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
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-045-10Valsartan100 in 1 CARTONTABLET1003
46708-045-30Valsartan30 in 1 BOTTLETABLET303
46708-045-71Valsartan500 in 1 BOTTLETABLET5003
46708-045-90Valsartan90 in 1 BOTTLETABLET903
46708-045-91Valsartan1000 in 1 BOTTLETABLET10003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALSARTANACTIVE INGREDIENT80M03YXJ7IVALSARTAN TABLET [ALEMBIC PHARMACEUTICALS LIMITED]1
VALSARTANACTIVE MOIETY80M03YXJ7IVALSARTAN TABLET [ALEMBIC PHARMACEUTICALS LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALSARTAN TABLET [ALEMBIC PHARMACEUTICALS LIMITED]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VALSARTAN TABLET [ALEMBIC PHARMACEUTICALS LIMITED]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VALSARTAN TABLET [ALEMBIC PHARMACEUTICALS LIMITED]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VALSARTAN TABLET [ALEMBIC PHARMACEUTICALS LIMITED]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVALSARTAN TABLET [ALEMBIC PHARMACEUTICALS LIMITED]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VALSARTAN TABLET [ALEMBIC PHARMACEUTICALS LIMITED]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALSARTAN TABLET [ALEMBIC PHARMACEUTICALS LIMITED]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVALSARTAN TABLET [ALEMBIC PHARMACEUTICALS LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALSARTAN TABLET [ALEMBIC PHARMACEUTICALS LIMITED]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGVALSARTAN TABLET [ALEMBIC PHARMACEUTICALS LIMITED]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVALSARTAN TABLET [ALEMBIC PHARMACEUTICALS LIMITED]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVALSARTAN TABLET [ALEMBIC PHARMACEUTICALS LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALSARTAN TABLET [ALEMBIC PHARMACEUTICALS LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-045VALSARTAN TABLET [ALEMBIC PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 5 package rows20230113_6e2cd953-88bf-4094-8ba8-2c9ba020f4d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349201valsartan 160 MG Oral TabletPSN6e2cd953-88bf-4094-8ba8-2c9ba020f4d73
349200valsartan 320 MG Oral TabletPSN6e2cd953-88bf-4094-8ba8-2c9ba020f4d73
349483valsartan 40 MG Oral TabletPSN6e2cd953-88bf-4094-8ba8-2c9ba020f4d73
349199valsartan 80 MG Oral TabletPSN6e2cd953-88bf-4094-8ba8-2c9ba020f4d73
349201valsartan 160 MG Oral TabletSCD6e2cd953-88bf-4094-8ba8-2c9ba020f4d73
349200valsartan 320 MG Oral TabletSCD6e2cd953-88bf-4094-8ba8-2c9ba020f4d73
349483valsartan 40 MG Oral TabletSCD6e2cd953-88bf-4094-8ba8-2c9ba020f4d73
349199valsartan 80 MG Oral TabletSCD6e2cd953-88bf-4094-8ba8-2c9ba020f4d73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-045-1046708004510100 TABLET in 1 CARTON (46708-045-10) 100 tablet2015-01-060000-00-00NoNoCurrent
46708-045-304670800453030 TABLET in 1 BOTTLE (46708-045-30) 30 tablet2015-01-060000-00-00NoNoCurrent
46708-045-7146708004571500 TABLET in 1 BOTTLE (46708-045-71) 500 tablet2015-01-060000-00-00NoNoCurrent
46708-045-904670800459090 TABLET in 1 BOTTLE (46708-045-90) 90 tablet2015-01-060000-00-00NoNoCurrent
46708-045-91467080045911000 TABLET in 1 BOTTLE (46708-045-91) 1000 tablet2015-01-060000-00-00NoNoCurrent