FDA.reportPublic FDA data

HYDRALAZINE HYDROCHLORIDE

Product NDC
72241-005
11-digit product format
722410005
Labeler code
72241
Product ID
72241-005_2be4a232-7aa2-44f8-ba8c-f5b64677c1b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydralazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Modavar Pharmaceuticals LLC
Application
ANDA203845
Marketing category
ANDA
Marketing start
2015-12-29
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
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
0284f4a6-db58-dacf-18fe-da73f4aeea88Product name420180827
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72241-005-05HYDRALAZINE HYDROCHLORIDE100 in 1 BOTTLETABLET1002
72241-005-11HYDRALAZINE HYDROCHLORIDE1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72241-005-11EA - Each72241-0059d1fb755-8ce2-4ce9-83c0-2eafa363930f12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72241-005HYDRALAZINE HYDROCHLORIDE TABLET [MODAVAR PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 2 package rows20240515_a456bc34-0c79-44f4-9119-50028a978f5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905222hydrALAZINE HCl 100 MG Oral TabletPSNa456bc34-0c79-44f4-9119-50028a978f5f2
905225hydrALAZINE HCl 25 MG Oral TabletPSNa456bc34-0c79-44f4-9119-50028a978f5f2
905395hydrALAZINE HCl 50 MG Oral TabletPSNa456bc34-0c79-44f4-9119-50028a978f5f2
905222hydralazine hydrochloride 100 MG Oral TabletSCDa456bc34-0c79-44f4-9119-50028a978f5f2
905225hydralazine hydrochloride 25 MG Oral TabletSCDa456bc34-0c79-44f4-9119-50028a978f5f2
905395hydralazine hydrochloride 50 MG Oral TabletSCDa456bc34-0c79-44f4-9119-50028a978f5f2
905395hydrALAZINE HCl 50 MG Oral TabletPSN2df51a19-a39a-0ec8-e063-6394a90a147c1
905395hydralazine hydrochloride 50 MG Oral TabletSCD2df51a19-a39a-0ec8-e063-6394a90a147c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72241-005-0572241000505100 TABLET in 1 BOTTLE (72241-005-05) 100 tablet2015-12-290000-00-00NoNoCurrent
72241-005-11722410005111000 TABLET in 1 BOTTLE (72241-005-11) 1000 tablet2015-12-290000-00-00NoNoCurrent