FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
68071-2055
11-digit product format
680712055
Labeler code
68071
Product ID
68071-2055_1d609c11-a29c-eb81-e063-6294a90a7472
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA040901
Marketing category
ANDA
Marketing start
2010-01-01
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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2055-32023-09-22C16284748780-1ba0f9c33-3678-a910-e053-dadaa90a0b85HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-62023-09-22C16284748780-1ba0f9c33-3678-a910-e053-dadaa90a0b85HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-92023-09-22C16284748780-1ba0f9c33-3678-a910-e053-dadaa90a0b85HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-32023-01-30C16284748780-1ba0f9c33-3678-a910-e053-dadaa90a0b85HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-62023-01-30C16284748780-1ba0f9c33-3678-a910-e053-dadaa90a0b85HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-92023-01-30C16284748780-1ba0f9c33-3678-a910-e053-dadaa90a0b85HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-32021-02-23C16284748780-1ba0f9c33-3678-a910-e053-dadaa90a0b85HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-62021-02-23C16284748780-1ba0f9c33-3678-a910-e053-dadaa90a0b85HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-92021-02-23C16284748780-1ba0f9c33-3678-a910-e053-dadaa90a0b85HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-32021-01-29C16284748780-1ba0f9c33-3678-a910-e053-dadaa90a0b85HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-62021-01-29C16284748780-1ba0f9c33-3678-a910-e053-dadaa90a0b85HYDRALAZINE HYDROCHLORIDE TABLETS, USP
68071-2055-92021-01-29C16284748780-1ba0f9c33-3678-a910-e053-dadaa90a0b85HYDRALAZINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2055-3Hydralazine Hydrochloride30 in 1 BOTTLETABLET304
68071-2055-6Hydralazine Hydrochloride60 in 1 BOTTLETABLET604
68071-2055-9Hydralazine Hydrochloride90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2055HYDRALAZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 3 package rows20240717_3b61d1b0-c699-67a8-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905199hydrALAZINE HCl 10 MG Oral TabletPSN3b61d1b0-c699-67a8-e054-00144ff88e884
905199hydralazine hydrochloride 10 MG Oral TabletSCD3b61d1b0-c699-67a8-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2055-36807120550330 TABLET in 1 BOTTLE (68071-2055-3) 30 tablet2010-01-010000-00-00NoNoCurrent
68071-2055-66807120550660 TABLET in 1 BOTTLE (68071-2055-6) 60 tablet2010-01-010000-00-00NoNoCurrent
68071-2055-96807120550990 TABLET in 1 BOTTLE (68071-2055-9) 90 tablet2010-01-010000-00-00NoNoCurrent