FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
50228-182
11-digit product format
502280182
Labeler code
50228
Product ID
50228-182_bcb83203-049e-1ddd-e053-2a95a90ae336
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
Application
ANDA205236
Marketing category
ANDA
Marketing start
2017-05-26
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 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
50228-182-01Hydralazine Hydrochloride100 in 1 BOTTLETABLET1007
50228-182-10Hydralazine Hydrochloride1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-182-01EA - Each50228-1827e452fe6-145a-40b2-8a87-e2bddd6d159e12019-11-12
50228-182-10EA - Each50228-1825f2c8336-66d5-4e59-b8ab-5808a677a15912019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-182HYDRALAZINE HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 2 package rows20210305_500b7f76-5f4e-4e7d-85c3-18b9f66d7504.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905199hydrALAZINE HCl 10 MG Oral TabletPSN4985994c-23ab-4409-bab6-5a17db767f13102
905199hydrALAZINE HCl 10 MG Oral TabletPSNe6d4b15e-1407-4783-94e4-9971dea68221102
905199hydralazine hydrochloride 10 MG Oral TabletSCDe6d4b15e-1407-4783-94e4-9971dea68221102
905199hydralazine hydrochloride 10 MG Oral TabletSCD4985994c-23ab-4409-bab6-5a17db767f13102
905199hydrALAZINE HCl 10 MG Oral TabletPSN4d1594dc-376b-44bd-8c0e-5de731dfb7f9100
905199hydrALAZINE HCl 10 MG Oral TabletPSN914d5b62-6f9b-4665-8562-689367c36230100
905199hydralazine hydrochloride 10 MG Oral TabletSCD4d1594dc-376b-44bd-8c0e-5de731dfb7f9100
905199hydralazine hydrochloride 10 MG Oral TabletSCD914d5b62-6f9b-4665-8562-689367c36230100
905199hydrALAZINE HCl 10 MG Oral TabletPSN500b7f76-5f4e-4e7d-85c3-18b9f66d75047
905222hydrALAZINE HCl 100 MG Oral TabletPSN500b7f76-5f4e-4e7d-85c3-18b9f66d75047
905225hydrALAZINE HCl 25 MG Oral TabletPSN500b7f76-5f4e-4e7d-85c3-18b9f66d75047
905395hydrALAZINE HCl 50 MG Oral TabletPSN500b7f76-5f4e-4e7d-85c3-18b9f66d75047
905199hydralazine hydrochloride 10 MG Oral TabletSCD500b7f76-5f4e-4e7d-85c3-18b9f66d75047
905222hydralazine hydrochloride 100 MG Oral TabletSCD500b7f76-5f4e-4e7d-85c3-18b9f66d75047
905225hydralazine hydrochloride 25 MG Oral TabletSCD500b7f76-5f4e-4e7d-85c3-18b9f66d75047
905395hydralazine hydrochloride 50 MG Oral TabletSCD500b7f76-5f4e-4e7d-85c3-18b9f66d75047
905199hydrALAZINE HCl 10 MG Oral TabletPSN41c019e3-7b07-5f12-e063-6294a90a53651
905199hydralazine hydrochloride 10 MG Oral TabletSCD41c019e3-7b07-5f12-e063-6294a90a53651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-182-0150228018201100 TABLET in 1 BOTTLE (50228-182-01) 100 tablet2017-05-260000-00-00NoNoCurrent
50228-182-10502280182101000 TABLET in 1 BOTTLE (50228-182-10) 1000 tablet2017-05-260000-00-00NoNoCurrent