Hydralazine Hydrochloride

Product NDC
51079-076
11-digit product format
510790076
Labeler code
51079
Product ID
51079-076_3a8625af-ede6-2b68-e063-6394a90a4536
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA088468
Marketing category
ANDA
Marketing start
2007-12-26
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFD171B778Y
Rxcui905199, 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
51079-076-01Hydralazine Hydrochloride1 in 1 BLISTER PACKTABLET115
51079-076-20Hydralazine Hydrochloride100 in 1 CARTONTABLET10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-076-01EA - Each51079-0768b76f720-9777-4128-a0d8-6896c1eae83112012-07-24
51079-076-20EA - Each51079-076c92ca3bb-2d53-47cb-9b92-e8c3351524a512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]7
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]7
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933HYDRALAZINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDRALAZINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDRALAZINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDRALAZINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDRALAZINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-076HYDRALAZINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]14Current NDC, Legacy NDC, 2 package rows20230404_493a8b7e-5bb1-4db2-91a7-77ed87864131.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905225hydrALAZINE HCl 25 MG Oral TabletPSNdb7500f3-f8a6-46b1-bb64-9727617a964318
905395hydrALAZINE HCl 50 MG Oral TabletPSNdb7500f3-f8a6-46b1-bb64-9727617a964318
905225hydralazine hydrochloride 25 MG Oral TabletSCDdb7500f3-f8a6-46b1-bb64-9727617a964318
905395hydralazine hydrochloride 50 MG Oral TabletSCDdb7500f3-f8a6-46b1-bb64-9727617a964318
905199hydrALAZINE HCl 10 MG Oral TabletPSN493a8b7e-5bb1-4db2-91a7-77ed8786413115
905225hydrALAZINE HCl 25 MG Oral TabletPSN493a8b7e-5bb1-4db2-91a7-77ed8786413115
905395hydrALAZINE HCl 50 MG Oral TabletPSN493a8b7e-5bb1-4db2-91a7-77ed8786413115
905199hydralazine hydrochloride 10 MG Oral TabletSCD493a8b7e-5bb1-4db2-91a7-77ed8786413115
905225hydralazine hydrochloride 25 MG Oral TabletSCD493a8b7e-5bb1-4db2-91a7-77ed8786413115
905395hydralazine hydrochloride 50 MG Oral TabletSCD493a8b7e-5bb1-4db2-91a7-77ed8786413115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-076-01510790076011 in 1 BLISTER PACKHistorical
51079-076-2051079007620100 BLISTER PACK in 1 CARTON (51079-076-20) / 1 TABLET in 1 BLISTER PACK (51079-076-01) 100 blister pack2007-12-260000-00-00NoNoCurrent