FDA.reportPublic FDA data

PREXXARTAN

Product NDC
76281-155
11-digit product format
762810155
Labeler code
76281
Product ID
76281-155_508c61d6-dbb1-5d06-e063-6394a90aa5ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREXXARTAN
Dosage form
SOLUTION
Route
ORAL
Labeler
AptaPharma Inc.
Application
NDA209139
Marketing category
NDA
Marketing start
2026-05-05
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PREXXARTAN
Listing expiration
2027-12-31

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
76281-155-56PREXXARTAN20 mL in 1 CUP, UNIT-DOSESOLUTION201
76281-155-64PREXXARTAN120 mL in 1 BOTTLESOLUTION1201
76281-155-82PREXXARTAN473 mL in 1 BOTTLESOLUTION4731
76281-155-99PREXXARTAN10 in 1 TRAYSOLUTION101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1996254valsartan 20 MG in 5 mL Oral SolutionPSN508c5de8-9c70-57f5-e063-6394a90af2951
1996254valsartan 4 MG/ML Oral SolutionSCD508c5de8-9c70-57f5-e063-6394a90af2951
1996254valsartan 20 MG in 5 mL Oral SolutionSY508c5de8-9c70-57f5-e063-6394a90af2951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76281-155-567628101555620 mL in 1 CUP, UNIT-DOSE (76281-155-56) 20 ml2026-05-05NoNoCurrent
76281-155-6476281015564120 mL in 1 BOTTLE (76281-155-64) 120 ml2026-05-05NoNoCurrent
76281-155-8276281015582473 mL in 1 BOTTLE (76281-155-82) 473 ml2026-05-05NoNoCurrent
76281-155-997628101559910 CUP, UNIT-DOSE in 1 TRAY (76281-155-99) / 20 mL in 1 CUP, UNIT-DOSE (76281-155-56) 2026-05-05NoNoCurrent