FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
50090-7210
11-digit product format
500907210
Labeler code
50090
Product ID
50090-7210_ee93239a-2a97-45d7-aeb8-a705343820dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA205236
Marketing category
ANDA
Marketing start
2017-05-26
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
50 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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7210-1Hydralazine Hydrochloride60 in 1 BOTTLETABLET601
50090-7210-2Hydralazine Hydrochloride180 in 1 BOTTLETABLET1801
50090-7210-3Hydralazine Hydrochloride90 in 1 BOTTLETABLET901
50090-7210-4Hydralazine Hydrochloride270 in 1 BOTTLETABLET2701

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7210-1EA - Each50090-72101a2c023a-db3a-43b1-9640-003a95cc687512024-09-09
50090-7210-2EA - Each50090-72107604bc2f-95a6-42c8-9910-86d8657f8d0212024-09-09
50090-7210-3EA - Each50090-7210e8bc49d1-62dc-4707-9beb-893e07d0af1312024-09-09
50090-7210-4EA - Each50090-7210965df0c0-679d-4d50-8bf5-95c274fedbef12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7210HYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 4 package rows20240808_a8194ac4-02d5-4aa1-b4e4-a3759f6f64b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905395hydrALAZINE HCl 50 MG Oral TabletPSNa8194ac4-02d5-4aa1-b4e4-a3759f6f64b51
905395hydralazine hydrochloride 50 MG Oral TabletSCDa8194ac4-02d5-4aa1-b4e4-a3759f6f64b51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7210-15009072100160 TABLET in 1 BOTTLE (50090-7210-1) 60 tablet2024-08-05NoNoCurrent
50090-7210-250090721002180 TABLET in 1 BOTTLE (50090-7210-2) 180 tablet2024-08-05NoNoCurrent
50090-7210-35009072100390 TABLET in 1 BOTTLE (50090-7210-3) 90 tablet2024-08-05NoNoCurrent
50090-7210-450090721004270 TABLET in 1 BOTTLE (50090-7210-4) 270 tablet2024-08-05NoNoCurrent