FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
71610-549
11-digit product format
716100549
Labeler code
71610
Product ID
71610-549_547e8073-67bc-4f54-bcc9-0fb525db6687
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA205236
Marketing category
ANDA
Marketing start
2021-03-04
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFD171B778Y
Rxcui905222, 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
71610-549-02Hydralazine Hydrochloride2000 in 1 BOTTLETABLET20002
71610-549-05Hydralazine Hydrochloride4200 in 1 BOTTLETABLET42002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-549HYDRALAZINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 2 package rows20240410_c2638ae6-a210-490f-8389-bbed6a3229c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905222hydrALAZINE HCl 100 MG Oral TabletPSNc2638ae6-a210-490f-8389-bbed6a3229c52
905225hydrALAZINE HCl 25 MG Oral TabletPSNc2638ae6-a210-490f-8389-bbed6a3229c52
905395hydrALAZINE HCl 50 MG Oral TabletPSNc2638ae6-a210-490f-8389-bbed6a3229c52
905222hydralazine hydrochloride 100 MG Oral TabletSCDc2638ae6-a210-490f-8389-bbed6a3229c52
905225hydralazine hydrochloride 25 MG Oral TabletSCDc2638ae6-a210-490f-8389-bbed6a3229c52
905395hydralazine hydrochloride 50 MG Oral TabletSCDc2638ae6-a210-490f-8389-bbed6a3229c52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-549-02716100549022000 TABLET in 1 BOTTLE (71610-549-02) 2000 tablet2024-04-01NoNoCurrent
71610-549-05716100549054200 TABLET in 1 BOTTLE (71610-549-05) 4200 tablet2021-04-300000-00-00NoNoCurrent