Hydralazine Hydrochloride

Product NDC
68071-2530
11-digit product format
680712530
Labeler code
68071
Product ID
68071-2530_d66cf0dc-f0b0-9873-e053-2a95a90a075a
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
Marketing end
0000-00-00
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
68071-2530-32025-01-30C16284748780-12cef2736-71ec-d83d-e063-dadaa90ab31fHYDRALAZINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2530-3Hydralazine Hydrochloride30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2530HYDRALAZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]3Legacy NDC, 1 package rows20230715_cba6a3d1-f76b-9adc-e053-2995a90aaad4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905395hydrALAZINE HCl 50 MG Oral TabletPSNcba6a3d1-f76b-9adc-e053-2995a90aaad43
905395hydralazine hydrochloride 50 MG Oral TabletSCDcba6a3d1-f76b-9adc-e053-2995a90aaad43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2530-36807125300330 TABLET in 1 BOTTLE (68071-2530-3) 30 tablet2021-09-100000-00-00NoNoCurrent