FDA.reportPublic FDA data

Valsartan

Product NDC
43547-368
11-digit product format
435470368
Labeler code
43547
Product ID
43547-368_bd8fb4f2-9d4a-4cf3-8b9e-cc5ba34bcea1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA204821
Marketing category
ANDA
Marketing start
2015-08-31
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
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
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-368-03Valsartan30 in 1 BOTTLETABLET3013
43547-368-09Valsartan90 in 1 BOTTLETABLET9013
43547-368-11Valsartan1000 in 1 BOTTLETABLET100013
43547-368-50Valsartan500 in 1 BOTTLETABLET50013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-368-09EA - Each43547-36801d1a83a-49df-4e23-a6d9-51b0abc3a3b212015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALSARTANACTIVE INGREDIENT80M03YXJ7IVALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
VALSARTANACTIVE MOIETY80M03YXJ7IVALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PVALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990VALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UVALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-368VALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]11Current NDC, Legacy NDC, 4 package rows20250427_26080940-bcd3-446d-9026-3ddfb58e281e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349199valsartan 80 MG Oral TabletPSN4e160647-a08e-40e8-b566-3e97a09c616a100
349199valsartan 80 MG Oral TabletSCD4e160647-a08e-40e8-b566-3e97a09c616a100
349201valsartan 160 MG Oral TabletPSNd9af6ba1-c760-4af6-b733-88e4892d4cb618
349199valsartan 80 MG Oral TabletPSNd9af6ba1-c760-4af6-b733-88e4892d4cb618
349201valsartan 160 MG Oral TabletSCDd9af6ba1-c760-4af6-b733-88e4892d4cb618
349199valsartan 80 MG Oral TabletSCDd9af6ba1-c760-4af6-b733-88e4892d4cb618
349201valsartan 160 MG Oral TabletPSN26080940-bcd3-446d-9026-3ddfb58e281e13
349200valsartan 320 MG Oral TabletPSN26080940-bcd3-446d-9026-3ddfb58e281e13
349483valsartan 40 MG Oral TabletPSN26080940-bcd3-446d-9026-3ddfb58e281e13
349199valsartan 80 MG Oral TabletPSN26080940-bcd3-446d-9026-3ddfb58e281e13
349201valsartan 160 MG Oral TabletSCD26080940-bcd3-446d-9026-3ddfb58e281e13
349200valsartan 320 MG Oral TabletSCD26080940-bcd3-446d-9026-3ddfb58e281e13
349483valsartan 40 MG Oral TabletSCD26080940-bcd3-446d-9026-3ddfb58e281e13
349199valsartan 80 MG Oral TabletSCD26080940-bcd3-446d-9026-3ddfb58e281e13
349199valsartan 80 MG Oral TabletPSN03af7d09-314a-fe85-e063-6294a90afa254
349199valsartan 80 MG Oral TabletSCD03af7d09-314a-fe85-e063-6294a90afa254

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-368-034354703680330 TABLET in 1 BOTTLE (43547-368-03) 30 tablet2015-08-310000-00-00NoNoCurrent
43547-368-094354703680990 TABLET in 1 BOTTLE (43547-368-09) 90 tablet2015-08-310000-00-00NoNoCurrent
43547-368-11435470368111000 TABLET in 1 BOTTLE (43547-368-11) 1000 tablet2015-08-310000-00-00NoNoCurrent
43547-368-5043547036850500 TABLET in 1 BOTTLE (43547-368-50) 500 tablet2015-08-310000-00-00NoNoCurrent