FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
67877-291
11-digit product format
678770291
Labeler code
67877
Product ID
67877-291_26a904df-7070-489e-b0e0-67167a817944
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA200737
Marketing category
ANDA
Marketing start
2009-11-24
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, 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
67877-291-01Hydralazine Hydrochloride100 in 1 BOTTLETABLET1005
67877-291-05Hydralazine Hydrochloride500 in 1 BOTTLETABLET5005
67877-291-10Hydralazine Hydrochloride1000 in 1 BOTTLETABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-291-00EA - Each67877-291a1233879-3041-4247-8c52-83ec4100950f12013-03-03
67877-291-20EA - Each67877-2913ad62e93-58a3-47d5-92f3-1d1d857b425712013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]4
HydralazineACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDRALAZINE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AHYDRALAZINE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XHYDRALAZINE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDRALAZINE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDRALAZINE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDRALAZINE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-291HYDRALAZINE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]5Current NDC, Legacy NDC, 3 package rows20171229_e7bfec3d-5222-4a26-8f99-6c2a28e14aa6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905199hydrALAZINE HCl 10 MG Oral TabletPSNe7bfec3d-5222-4a26-8f99-6c2a28e14aa65
905222hydrALAZINE HCl 100 MG Oral TabletPSNe7bfec3d-5222-4a26-8f99-6c2a28e14aa65
905225hydrALAZINE HCl 25 MG Oral TabletPSNe7bfec3d-5222-4a26-8f99-6c2a28e14aa65
905395hydrALAZINE HCl 50 MG Oral TabletPSNe7bfec3d-5222-4a26-8f99-6c2a28e14aa65
905199hydralazine hydrochloride 10 MG Oral TabletSCDe7bfec3d-5222-4a26-8f99-6c2a28e14aa65
905222hydralazine hydrochloride 100 MG Oral TabletSCDe7bfec3d-5222-4a26-8f99-6c2a28e14aa65
905225hydralazine hydrochloride 25 MG Oral TabletSCDe7bfec3d-5222-4a26-8f99-6c2a28e14aa65
905395hydralazine hydrochloride 50 MG Oral TabletSCDe7bfec3d-5222-4a26-8f99-6c2a28e14aa65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-291-0167877029101100 TABLET in 1 BOTTLE (67877-291-01) 100 tablet2009-11-240000-00-00NoNoCurrent
67877-291-0567877029105500 TABLET in 1 BOTTLE (67877-291-05) 500 tablet2009-11-240000-00-00NoNoCurrent
67877-291-10678770291101000 TABLET in 1 BOTTLE (67877-291-10) 1000 tablet2009-11-240000-00-00NoNoCurrent