FDA.reportPublic FDA data

Valsartan

Product NDC
31722-747
11-digit product format
317220747
Labeler code
31722
Product ID
31722-747_2b44fd7a-fd5a-984d-e063-6294a90a3fff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA203311
Marketing category
ANDA
Marketing start
2015-01-05
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
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
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-747-05Valsartan500 in 1 BOTTLETABLET, FILM COATED5008
31722-747-30Valsartan30 in 1 BOTTLETABLET, FILM COATED308
31722-747-31Valsartan10 in 1 BLISTER PACKTABLET, FILM COATED108
31722-747-32Valsartan100 in 1 BLISTER PACKTABLET, FILM COATED1008
31722-747-90Valsartan90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-747VALSARTAN (VALSARTAN) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 5 package rows20250112_0ff36e83-b307-42db-a2ab-bae3f6805c20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349201valsartan 160 MG Oral TabletPSN0ff36e83-b307-42db-a2ab-bae3f6805c208
349200valsartan 320 MG Oral TabletPSN0ff36e83-b307-42db-a2ab-bae3f6805c208
349483valsartan 40 MG Oral TabletPSN0ff36e83-b307-42db-a2ab-bae3f6805c208
349199valsartan 80 MG Oral TabletPSN0ff36e83-b307-42db-a2ab-bae3f6805c208
349201valsartan 160 MG Oral TabletSCD0ff36e83-b307-42db-a2ab-bae3f6805c208
349200valsartan 320 MG Oral TabletSCD0ff36e83-b307-42db-a2ab-bae3f6805c208
349483valsartan 40 MG Oral TabletSCD0ff36e83-b307-42db-a2ab-bae3f6805c208
349199valsartan 80 MG Oral TabletSCD0ff36e83-b307-42db-a2ab-bae3f6805c208

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-747-0531722074705500 TABLET, FILM COATED in 1 BOTTLE (31722-747-05) 2015-01-050000-00-00NoNoCurrent
31722-747-303172207473030 TABLET, FILM COATED in 1 BOTTLE (31722-747-30) 2015-01-050000-00-00NoNoCurrent
31722-747-313172207473110 TABLET, FILM COATED in 1 BLISTER PACK (31722-747-31) 2015-01-050000-00-00NoNoCurrent
31722-747-3231722074732100 TABLET, FILM COATED in 1 BLISTER PACK (31722-747-32) 2015-01-050000-00-00NoNoCurrent
31722-747-903172207479090 TABLET, FILM COATED in 1 BOTTLE (31722-747-90) 2015-01-050000-00-00NoNoCurrent