FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
60687-833
11-digit product format
606870833
Labeler code
60687
Product ID
60687-833_22cbafb8-fd5b-19b1-e063-6394a90a2b4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA040858
Marketing category
ANDA
Marketing start
2024-03-15
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
Rxcui905199, 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
60687-833-01Hydralazine Hydrochloride100 in 1 CARTONTABLET1002
60687-833-11Hydralazine Hydrochloride1 in 1 BLISTER PACKTABLET12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-833-01EA - Each60687-833fa95ff0d-a39e-4073-ad28-a75a7f05857012024-03-12
60687-833-11EA - Each60687-833f9f6be56-3d83-4501-afad-fb720b8166ca12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-833HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2Current NDC, 2 package rows20240925_2e82655e-8435-46fa-b734-8e7c6e803453.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905225hydrALAZINE HCl 25 MG Oral TabletPSNa1066707-2391-4918-8ded-600c017fde484
905395hydrALAZINE HCl 50 MG Oral TabletPSNa1066707-2391-4918-8ded-600c017fde484
905225hydralazine hydrochloride 25 MG Oral TabletSCDa1066707-2391-4918-8ded-600c017fde484
905395hydralazine hydrochloride 50 MG Oral TabletSCDa1066707-2391-4918-8ded-600c017fde484
905199hydrALAZINE HCl 10 MG Oral TabletPSN2e82655e-8435-46fa-b734-8e7c6e8034532
905225hydrALAZINE HCl 25 MG Oral TabletPSN2e82655e-8435-46fa-b734-8e7c6e8034532
905395hydrALAZINE HCl 50 MG Oral TabletPSN2e82655e-8435-46fa-b734-8e7c6e8034532
905199hydralazine hydrochloride 10 MG Oral TabletSCD2e82655e-8435-46fa-b734-8e7c6e8034532
905225hydralazine hydrochloride 25 MG Oral TabletSCD2e82655e-8435-46fa-b734-8e7c6e8034532
905395hydralazine hydrochloride 50 MG Oral TabletSCD2e82655e-8435-46fa-b734-8e7c6e8034532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-833-0160687083301100 BLISTER PACK in 1 CARTON (60687-833-01) / 1 TABLET in 1 BLISTER PACK (60687-833-11) 100 blister pack2024-03-15NoNoCurrent
60687-833-11606870833111 in 1 BLISTER PACKHistorical