FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
50111-397
11-digit product format
501110397
Labeler code
50111
Product ID
50111-397_faf6c313-03e6-4bf8-ac9f-65642ae10097
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA089098
Marketing category
ANDA
Marketing start
1990-09-30
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
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
0284f4a6-db58-dacf-18fe-da73f4aeea88Product name420180827
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50111-397-01Hydralazine Hydrochloride100 in 1 BOTTLETABLET10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50111-397-01EA - Each50111-397bac615e7-15a5-42bf-a47c-ae0e4440fde512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET [PLIVA INC.]4
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET [PLIVA INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933HYDRALAZINE HYDROCHLORIDE TABLET [PLIVA INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDRALAZINE HYDROCHLORIDE TABLET [PLIVA INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET [PLIVA INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDRALAZINE HYDROCHLORIDE TABLET [PLIVA INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDRALAZINE HYDROCHLORIDE TABLET [PLIVA INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDRALAZINE HYDROCHLORIDE TABLET [PLIVA INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50111-397HYDRALAZINE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]10Current NDC, Legacy NDC, 1 package rows20211104_ddbbdb09-3202-42d7-bbb0-08331dde2f54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905199hydrALAZINE HCl 10 MG Oral TabletPSNddbbdb09-3202-42d7-bbb0-08331dde2f5410
905222hydrALAZINE HCl 100 MG Oral TabletPSNddbbdb09-3202-42d7-bbb0-08331dde2f5410
905225hydrALAZINE HCl 25 MG Oral TabletPSNddbbdb09-3202-42d7-bbb0-08331dde2f5410
905395hydrALAZINE HCl 50 MG Oral TabletPSNddbbdb09-3202-42d7-bbb0-08331dde2f5410
905199hydralazine hydrochloride 10 MG Oral TabletSCDddbbdb09-3202-42d7-bbb0-08331dde2f5410
905222hydralazine hydrochloride 100 MG Oral TabletSCDddbbdb09-3202-42d7-bbb0-08331dde2f5410
905225hydralazine hydrochloride 25 MG Oral TabletSCDddbbdb09-3202-42d7-bbb0-08331dde2f5410
905395hydralazine hydrochloride 50 MG Oral TabletSCDddbbdb09-3202-42d7-bbb0-08331dde2f5410
905222hydrALAZINE HCl 100 MG Oral TabletPSNd9892176-d4a6-4edb-92b9-5f56243f3d221
905222hydralazine hydrochloride 100 MG Oral TabletSCDd9892176-d4a6-4edb-92b9-5f56243f3d221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50111-397-0150111039701100 TABLET in 1 BOTTLE (50111-397-01) 100 tablet1990-09-300000-00-00NoNoCurrent