Hydralazine Hydrochloride

Product NDC
72162-1536
11-digit product format
721621536
Labeler code
72162
Product ID
72162-1536_4bd26845-6a7f-4298-9a57-e096adc14b99
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
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
Rxcui905225

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
72162-1536-0Hydralazine Hydrochloride1000 in 1 BOTTLETABLET1000101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1536-0EA - Each72162-1536b46c6f33-bbf2-4b54-837c-a178c7ec563612024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1536HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20240221_8224aa3d-b1b9-40df-93fd-a91c6a158898.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905225hydrALAZINE HCl 25 MG Oral TabletPSN8224aa3d-b1b9-40df-93fd-a91c6a158898101
905225hydralazine hydrochloride 25 MG Oral TabletSCD8224aa3d-b1b9-40df-93fd-a91c6a158898101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1536-0721621536001000 TABLET in 1 BOTTLE (72162-1536-0) 1000 tablet2024-02-05NoNoHistorical