Valsartan

Product NDC
31722-153
11-digit product format
317220153
Labeler code
31722
Product ID
31722-153_4b026ec3-7e85-69ee-e063-6394a90a8c7f
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
2021-06-23
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
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
31722-153-05Valsartan500 in 1 BOTTLETABLET, FILM COATED5002
31722-153-30Valsartan30 in 1 BOTTLETABLET, FILM COATED302
31722-153-31Valsartan10 in 1 BLISTER PACKTABLET, FILM COATED102
31722-153-32Valsartan100 in 1 BLISTER PACKTABLET, FILM COATED1002
31722-153-90Valsartan90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-153-90EA - Each31722-153f992f900-4563-46b2-9abc-5d0fe7735c2e12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-153VALSARTAN (VALSARTAN) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 5 package rows20210728_d6e84105-9394-4ef0-928c-20d07d3fbaa9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349201valsartan 160 MG Oral TabletPSN6e9c4c57-e2c9-461b-9c09-669d3ada4c1a102
349201valsartan 160 MG Oral TabletSCD6e9c4c57-e2c9-461b-9c09-669d3ada4c1a102
349201valsartan 160 MG Oral TabletPSN688b5c82-2eba-445c-869e-60609f5db86a3
349201valsartan 160 MG Oral TabletSCD688b5c82-2eba-445c-869e-60609f5db86a3
349201valsartan 160 MG Oral TabletPSN0878f27e-5368-c93f-e063-6394a90a10862
349201valsartan 160 MG Oral TabletPSNf756009f-f04f-6518-e053-6294a90a79ed2
349201valsartan 160 MG Oral TabletPSNf59f71d3-c143-43e5-ac22-0b1d741f4a812
349201valsartan 160 MG Oral TabletPSNd6e84105-9394-4ef0-928c-20d07d3fbaa92
349200valsartan 320 MG Oral TabletPSN0878f27e-5368-c93f-e063-6394a90a10862
349200valsartan 320 MG Oral TabletPSNd6e84105-9394-4ef0-928c-20d07d3fbaa92
349483valsartan 40 MG Oral TabletPSN0878f27e-5368-c93f-e063-6394a90a10862
349483valsartan 40 MG Oral TabletPSNd6e84105-9394-4ef0-928c-20d07d3fbaa92
349199valsartan 80 MG Oral TabletPSNd6e84105-9394-4ef0-928c-20d07d3fbaa92
349199valsartan 80 MG Oral TabletPSN0878f27e-5368-c93f-e063-6394a90a10862
349201valsartan 160 MG Oral TabletSCDd6e84105-9394-4ef0-928c-20d07d3fbaa92
349201valsartan 160 MG Oral TabletSCDf59f71d3-c143-43e5-ac22-0b1d741f4a812
349201valsartan 160 MG Oral TabletSCDf756009f-f04f-6518-e053-6294a90a79ed2
349201valsartan 160 MG Oral TabletSCD0878f27e-5368-c93f-e063-6394a90a10862
349200valsartan 320 MG Oral TabletSCD0878f27e-5368-c93f-e063-6394a90a10862
349200valsartan 320 MG Oral TabletSCDd6e84105-9394-4ef0-928c-20d07d3fbaa92
349483valsartan 40 MG Oral TabletSCDd6e84105-9394-4ef0-928c-20d07d3fbaa92
349483valsartan 40 MG Oral TabletSCD0878f27e-5368-c93f-e063-6394a90a10862
349199valsartan 80 MG Oral TabletSCD0878f27e-5368-c93f-e063-6394a90a10862
349199valsartan 80 MG Oral TabletSCDd6e84105-9394-4ef0-928c-20d07d3fbaa92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-153-0531722015305500 TABLET, FILM COATED in 1 BOTTLE (31722-153-05) 2021-06-230000-00-00NoNoCurrent
31722-153-303172201533030 TABLET, FILM COATED in 1 BOTTLE (31722-153-30) 2021-06-230000-00-00NoNoCurrent
31722-153-313172201533110 TABLET, FILM COATED in 1 BLISTER PACK (31722-153-31) 2021-06-230000-00-00NoNoCurrent
31722-153-3231722015332100 TABLET, FILM COATED in 1 BLISTER PACK (31722-153-32) 2021-06-230000-00-00NoNoCurrent
31722-153-903172201539090 TABLET, FILM COATED in 1 BOTTLE (31722-153-90) 2021-06-230000-00-00NoNoCurrent