FDA.reportPublic FDA data

HYDRALAZINE HYDROCHLORIDE

Product NDC
71209-018
11-digit product format
712090018
Labeler code
71209
Product ID
71209-018_4cdbf75c-b17f-4c40-bd7c-7b07668e9659
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydralazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA203845
Marketing category
ANDA
Marketing start
2015-12-29
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFD171B778Y
Rxcui905222, 905225, 905395

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3137695-e199-b3b3-2950-87a8ac429689Product name520260316
e9ed2ee5-d109-4795-bffe-c3b047717749Product name220250107
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
0284f4a6-db58-dacf-18fe-da73f4aeea88Product name420180827
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71209-018-05HYDRALAZINE HYDROCHLORIDE100 in 1 BOTTLETABLET1006
71209-018-11HYDRALAZINE HYDROCHLORIDE1000 in 1 BOTTLETABLET10006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-018HYDRALAZINE HYDROCHLORIDE TABLET [CADILA PHARMACEUTICALS LIMITED]6Current NDC, Legacy NDC, 2 package rows20221230_3a7562a8-2f67-4411-ac4a-ab7924193e82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905222hydrALAZINE HCl 100 MG Oral TabletPSN3a7562a8-2f67-4411-ac4a-ab7924193e826
905225hydrALAZINE HCl 25 MG Oral TabletPSN3a7562a8-2f67-4411-ac4a-ab7924193e826
905395hydrALAZINE HCl 50 MG Oral TabletPSN3a7562a8-2f67-4411-ac4a-ab7924193e826
905222hydralazine hydrochloride 100 MG Oral TabletSCD3a7562a8-2f67-4411-ac4a-ab7924193e826
905225hydralazine hydrochloride 25 MG Oral TabletSCD3a7562a8-2f67-4411-ac4a-ab7924193e826
905395hydralazine hydrochloride 50 MG Oral TabletSCD3a7562a8-2f67-4411-ac4a-ab7924193e826

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71209-018-0571209001805100 TABLET in 1 BOTTLE (71209-018-05) 100 tablet2015-12-290000-00-00NoNoCurrent
71209-018-11712090018111000 TABLET in 1 BOTTLE (71209-018-11) 1000 tablet2015-12-290000-00-00NoNoCurrent