FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
71335-0202
11-digit product format
713350202
Labeler code
71335
Product ID
71335-0202_15abfa42-46a4-441c-aca2-25377e0719db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040901
Marketing category
ANDA
Marketing start
2010-01-01
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFD171B778Y
Rxcui905222, 905225

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
71335-0202-1Hydralazine Hydrochloride30 in 1 BOTTLETABLET307
71335-0202-2Hydralazine Hydrochloride60 in 1 BOTTLETABLET607
71335-0202-3Hydralazine Hydrochloride90 in 1 BOTTLETABLET907
71335-0202-4Hydralazine Hydrochloride10 in 1 BOTTLETABLET107
71335-0202-5Hydralazine Hydrochloride100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0202-1EA - Each71335-020227bedd88-19a9-4eea-ab51-f2ad306a1ed312018-03-08
71335-0202-2EA - Each71335-0202f2ae87a2-7597-4fa3-aba3-b7d428c5cbde12018-03-08
71335-0202-3EA - Each71335-02021eb1b68c-b06b-4d21-81bc-8d16ebbaec5a12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0202HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 5 package rows20250331_d2d98842-ff32-4a61-94e0-60e06919948f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905222hydrALAZINE HCl 100 MG Oral TabletPSNd2d98842-ff32-4a61-94e0-60e06919948f7
905225hydrALAZINE HCl 25 MG Oral TabletPSNd2d98842-ff32-4a61-94e0-60e06919948f7
905222hydralazine hydrochloride 100 MG Oral TabletSCDd2d98842-ff32-4a61-94e0-60e06919948f7
905225hydralazine hydrochloride 25 MG Oral TabletSCDd2d98842-ff32-4a61-94e0-60e06919948f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0202-17133502020130 TABLET in 1 BOTTLE (71335-0202-1) 30 tablet2017-06-300000-00-00NoNoCurrent
71335-0202-27133502020260 TABLET in 1 BOTTLE (71335-0202-2) 60 tablet2017-06-300000-00-00NoNoCurrent
71335-0202-37133502020390 TABLET in 1 BOTTLE (71335-0202-3) 90 tablet2017-06-300000-00-00NoNoCurrent
71335-0202-47133502020410 TABLET in 1 BOTTLE (71335-0202-4) 10 tablet2017-06-30NoNoCurrent
71335-0202-571335020205100 TABLET in 1 BOTTLE (71335-0202-5) 100 tablet2017-06-30NoNoCurrent