FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
0904-7448
11-digit product format
009047448
Labeler code
0904
Product ID
0904-7448_73a8ca83-9f63-4264-b36f-e133d98d5002
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA040858
Marketing category
ANDA
Marketing start
2025-01-03
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 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
0904-7448-61Hydralazine Hydrochloride100 in 1 CARTONTABLET1002
0904-7448-61Hydralazine Hydrochloride1 in 1 BLISTER PACKTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7448HYDRALAZINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]2Current NDC, 2 package rows20250223_b6ccd35e-f69c-4eef-a456-905e030ae911.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905225hydrALAZINE HCl 25 MG Oral TabletPSN336b11da-e592-4386-921f-3c136d754f2a3
905395hydrALAZINE HCl 50 MG Oral TabletPSN336b11da-e592-4386-921f-3c136d754f2a3
905225hydralazine hydrochloride 25 MG Oral TabletSCD336b11da-e592-4386-921f-3c136d754f2a3
905395hydralazine hydrochloride 50 MG Oral TabletSCD336b11da-e592-4386-921f-3c136d754f2a3
905199hydrALAZINE HCl 10 MG Oral TabletPSNb6ccd35e-f69c-4eef-a456-905e030ae9112
905222hydrALAZINE HCl 100 MG Oral TabletPSNb6ccd35e-f69c-4eef-a456-905e030ae9112
905225hydrALAZINE HCl 25 MG Oral TabletPSNb6ccd35e-f69c-4eef-a456-905e030ae9112
905395hydrALAZINE HCl 50 MG Oral TabletPSNb6ccd35e-f69c-4eef-a456-905e030ae9112
905199hydralazine hydrochloride 10 MG Oral TabletSCDb6ccd35e-f69c-4eef-a456-905e030ae9112
905222hydralazine hydrochloride 100 MG Oral TabletSCDb6ccd35e-f69c-4eef-a456-905e030ae9112
905225hydralazine hydrochloride 25 MG Oral TabletSCDb6ccd35e-f69c-4eef-a456-905e030ae9112
905395hydralazine hydrochloride 50 MG Oral TabletSCDb6ccd35e-f69c-4eef-a456-905e030ae9112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7448-6100904744861100 BLISTER PACK in 1 CARTON (0904-7448-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2025-01-03NoNoCurrent