FDA.reportPublic FDA data

HYDRALAZINE HYDROCHLORIDE

Product NDC
51655-305
11-digit product format
516550305
Labeler code
51655
Product ID
51655-305_48eaeb02-b2f5-5a36-e063-6394a90ac5e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydralazine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA086242
Marketing category
ANDA
Marketing start
2020-05-20
Marketing end
2026-08-31
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HYDRALAZINE HYDROCHLORIDE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDRALAZINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFD171B778Y
Rxcui905225

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
51655-305-262023-11-14C16284748780-1f386c649-b290-0266-e053-dadaa90a7c1aRx only
51655-305-832023-11-14C16284748780-1f386c649-b290-0266-e053-dadaa90a7c1aRx only
51655-305-262023-01-30C16284748780-1f386c649-b290-0266-e053-dadaa90a7c1aRx only
51655-305-832023-01-30C16284748780-1f386c649-b290-0266-e053-dadaa90a7c1aRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-305-26HYDRALAZINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED905
51655-305-83HYDRALAZINE HYDROCHLORIDE180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-305HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20240720_ab1c6f37-3b64-23fb-e053-2995a90a932f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905225hydrALAZINE HCl 25 MG Oral TabletPSNab1c6f37-3b64-23fb-e053-2995a90a932f5
905225hydralazine hydrochloride 25 MG Oral TabletSCDab1c6f37-3b64-23fb-e053-2995a90a932f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-305-265165503052690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-305-26) 2020-05-202026-08-31NoNoCurrent
51655-305-8351655030583180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-305-83) 2020-05-282026-08-31NoNoCurrent