FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
71335-9756
11-digit product format
713359756
Labeler code
71335
Product ID
71335-9756_b9ddda4a-9598-451d-abb2-f13f4ba4e67f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205236
Marketing category
ANDA
Marketing start
2017-05-26
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydralazine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDRALAZINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFD171B778Y
Rxcui905395

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3137695-e199-b3b3-2950-87a8ac429689Product name520260316
e9ed2ee5-d109-4795-bffe-c3b047717749Product name220250107
0284f4a6-db58-dacf-18fe-da73f4aeea88Product name420180827
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-9756-1Hydralazine Hydrochloride30 in 1 BOTTLETABLET30100
71335-9756-2Hydralazine Hydrochloride60 in 1 BOTTLETABLET60100
71335-9756-3Hydralazine Hydrochloride120 in 1 BOTTLETABLET120100
71335-9756-4Hydralazine Hydrochloride90 in 1 BOTTLETABLET90100
71335-9756-5Hydralazine Hydrochloride10 in 1 BOTTLETABLET10100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9756HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]100Current NDC, 5 package rows20230726_62475f78-5410-43c2-a11d-54a8363c3ae1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905395hydrALAZINE HCl 50 MG Oral TabletPSN62475f78-5410-43c2-a11d-54a8363c3ae1100
905395hydralazine hydrochloride 50 MG Oral TabletSCD62475f78-5410-43c2-a11d-54a8363c3ae1100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9756-17133597560130 TABLET in 1 BOTTLE (71335-9756-1) 30 tablet2023-07-25NoNoHistorical
71335-9756-27133597560260 TABLET in 1 BOTTLE (71335-9756-2) 60 tablet2023-07-25NoNoHistorical
71335-9756-371335975603120 TABLET in 1 BOTTLE (71335-9756-3) 120 tablet2023-07-25NoNoHistorical
71335-9756-47133597560490 TABLET in 1 BOTTLE (71335-9756-4) 90 tablet2023-07-25NoNoHistorical
71335-9756-57133597560510 TABLET in 1 BOTTLE (71335-9756-5) 10 tablet2023-07-25NoNoHistorical