FDA.reportPublic FDA data

Valsartan

Product NDC
68180-276
11-digit product format
681800276
Labeler code
68180
Product ID
68180-276_b0ac78ab-2315-4aca-a405-bd86b8a08692
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA201677
Marketing category
ANDA
Marketing start
2015-01-05
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
68180-276-01Valsartan100 in 1 BOTTLETABLET10019
68180-276-06Valsartan30 in 1 BOTTLETABLET3019
68180-276-11Valsartan10 in 1 BLISTER PACKTABLET1019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-276-01EA - Each68180-276a5fe80a1-9410-46ad-aae8-7c5590f2fc5c12015-02-02
68180-276-06EA - Each68180-2762b4ef61e-9169-40ce-bccf-121c868d35aa12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALSARTANACTIVE INGREDIENT80M03YXJ7IVALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]8
VALSARTANACTIVE MOIETY80M03YXJ7IVALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]8
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]8
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BVALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]8
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJVALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-276VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]19Current NDC, Legacy NDC, 3 package rows20240323_9eb9d98e-7057-4ca0-91ab-2030bc0120a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349201valsartan 160 MG Oral TabletPSN9eb9d98e-7057-4ca0-91ab-2030bc0120a619
349200valsartan 320 MG Oral TabletPSN9eb9d98e-7057-4ca0-91ab-2030bc0120a619
349483valsartan 40 MG Oral TabletPSN9eb9d98e-7057-4ca0-91ab-2030bc0120a619
349199valsartan 80 MG Oral TabletPSN9eb9d98e-7057-4ca0-91ab-2030bc0120a619
349201valsartan 160 MG Oral TabletSCD9eb9d98e-7057-4ca0-91ab-2030bc0120a619
349200valsartan 320 MG Oral TabletSCD9eb9d98e-7057-4ca0-91ab-2030bc0120a619
349483valsartan 40 MG Oral TabletSCD9eb9d98e-7057-4ca0-91ab-2030bc0120a619
349199valsartan 80 MG Oral TabletSCD9eb9d98e-7057-4ca0-91ab-2030bc0120a619

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-276-0168180027601100 TABLET in 1 BOTTLE (68180-276-01) 100 tablet2015-01-050000-00-00NoNoCurrent
68180-276-066818002760630 TABLET in 1 BOTTLE (68180-276-06) 30 tablet2015-01-050000-00-00NoNoCurrent
68180-276-116818002761110 TABLET in 1 BLISTER PACK (68180-276-11) 10 tablet2015-01-050000-00-00NoNoCurrent