Valsartan

Product NDC
70954-310
11-digit product format
709540310
Labeler code
70954
Product ID
70954-310_12e344cb-87c4-44a1-a59a-c6bcaaa6cb2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
SOLUTION
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA214102
Marketing category
ANDA
Marketing start
2021-11-02
Substance
VALSARTAN
Active strength
4 mg/mL
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
VALSARTAN4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80M03YXJ7I
Rxcui1996254

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
70954-310-10Valsartan120 mL in 1 BOTTLE, PLASTICSOLUTION1203
70954-310-20Valsartan473 mL in 1 BOTTLE, PLASTICSOLUTION4733

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-310-10ML - Milliliter70954-31098ec1ccd-ec0f-4204-be61-9c619b4d35ca12024-02-14
70954-310-20ML - Milliliter70954-310acaf8f20-88c2-4ba2-90f0-57119355955f12025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-310VALSARTAN SOLUTION [ANI PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20230919_959b6790-feb7-45a9-9ea4-0ee1a7fce048.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1996254valsartan 20 MG in 5 mL Oral SolutionPSN959b6790-feb7-45a9-9ea4-0ee1a7fce0483
1996254valsartan 4 MG/ML Oral SolutionSCD959b6790-feb7-45a9-9ea4-0ee1a7fce0483
1996254valsartan 20 MG in 5 mL Oral SolutionSY959b6790-feb7-45a9-9ea4-0ee1a7fce0483

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-310-1070954031010120 mL in 1 BOTTLE, PLASTIC (70954-310-10) 120 ml2021-11-020000-00-00NoNoCurrent
70954-310-2070954031020473 mL in 1 BOTTLE, PLASTIC (70954-310-20) 473 ml2021-11-020000-00-00NoNoCurrent