FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
68462-341
11-digit product format
684620341
Labeler code
68462
Product ID
68462-341_617acbb5-012a-416f-bf6c-fd766a25711c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA090527
Marketing category
ANDA
Marketing start
2009-05-29
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFD171B778Y
Rxcui905199, 905222, 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
68462-341-01Hydralazine Hydrochloride100 in 1 BOTTLETABLET1009
68462-341-05Hydralazine Hydrochloride500 in 1 BOTTLETABLET5009
68462-341-10Hydralazine Hydrochloride1000 in 1 BOTTLETABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-341-01EA - Each68462-3414f2e1a83-9765-4042-b2c0-96fa0bd26cb412012-07-24
68462-341-05EA - Each68462-3418a4996cf-1b21-4195-a75a-22f667f1da0d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
MANNITOLINACTIVE INGREDIENT3OWL53L36AHYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-341HYDRALAZINE HYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]9Current NDC, Legacy NDC, 3 package rows20241207_37ba0233-ed75-498a-a067-6220da573653.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905199hydrALAZINE HCl 10 MG Oral TabletPSN37ba0233-ed75-498a-a067-6220da5736539
905222hydrALAZINE HCl 100 MG Oral TabletPSN37ba0233-ed75-498a-a067-6220da5736539
905225hydrALAZINE HCl 25 MG Oral TabletPSN37ba0233-ed75-498a-a067-6220da5736539
905395hydrALAZINE HCl 50 MG Oral TabletPSN37ba0233-ed75-498a-a067-6220da5736539
905199hydralazine hydrochloride 10 MG Oral TabletSCD37ba0233-ed75-498a-a067-6220da5736539
905222hydralazine hydrochloride 100 MG Oral TabletSCD37ba0233-ed75-498a-a067-6220da5736539
905225hydralazine hydrochloride 25 MG Oral TabletSCD37ba0233-ed75-498a-a067-6220da5736539
905395hydralazine hydrochloride 50 MG Oral TabletSCD37ba0233-ed75-498a-a067-6220da5736539

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68462-341-0168462034101100 TABLET in 1 BOTTLE (68462-341-01) 100 tablet2009-05-29NoNoCurrent
68462-341-0568462034105500 TABLET in 1 BOTTLE (68462-341-05) 500 tablet2009-05-29NoNoCurrent
68462-341-10684620341101000 TABLET in 1 BOTTLE (68462-341-10) 1000 tablet2009-05-29NoNoCurrent