FDA.reportPublic FDA data

HYDRALAZINE HYDROCHLORIDE

Product NDC
51655-916
11-digit product format
516550916
Labeler code
51655
Product ID
51655-916_4974183f-5839-7ea9-e063-6294a90ad99e
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
2020-05-26
Marketing end
2026-08-31
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFD171B778Y
Rxcui905395

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
51655-916-262024-02-19C16284748780-1f386c64a-0da6-0266-e053-dadaa90a7c1aRx only
51655-916-262023-01-30C16284748780-1f386c64a-0da6-0266-e053-dadaa90a7c1aRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-916-26HYDRALAZINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904
51655-916-52HYDRALAZINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-916HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 2 package rows20240220_ada28f78-e933-7acf-e053-2995a90ae316.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905395hydrALAZINE HCl 50 MG Oral TabletPSNada28f78-e933-7acf-e053-2995a90ae3164
905395hydralazine hydrochloride 50 MG Oral TabletSCDada28f78-e933-7acf-e053-2995a90ae3164

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-916-265165509162690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-916-26) 2020-05-262026-08-31NoNoCurrent
51655-916-525165509165230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-916-52) 2023-07-122026-08-31NoNoHistorical