HydrALAZINE Hydrochloride

Product NDC
71205-072
11-digit product format
712050072
Labeler code
71205
Product ID
71205-072_5696b87a-c388-4cd2-b22b-b2861c28d800
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HydrALAZINE Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA200770
Marketing category
ANDA
Marketing start
2013-06-30
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
71205-072-30HydrALAZINE Hydrochloride30 in 1 BOTTLETABLET303
71205-072-60HydrALAZINE Hydrochloride60 in 1 BOTTLETABLET603
71205-072-90HydrALAZINE Hydrochloride90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-072-90EA - Each71205-072d3cfca08-daf8-416a-9adb-e49fd88f1d2112018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-072HYDRALAZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191030_dfd60a79-2a30-41e6-b000-a144730099a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905395hydrALAZINE HCl 50 MG Oral TabletPSNdfd60a79-2a30-41e6-b000-a144730099a83
905395hydralazine hydrochloride 50 MG Oral TabletSCDdfd60a79-2a30-41e6-b000-a144730099a83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-072-307120500723030 TABLET in 1 BOTTLE (71205-072-30) 30 tablet2018-07-020000-00-00NoNoCurrent
71205-072-607120500726060 TABLET in 1 BOTTLE (71205-072-60) 60 tablet2018-07-020000-00-00NoNoCurrent
71205-072-907120500729090 TABLET in 1 BOTTLE (71205-072-90) 90 tablet2018-07-020000-00-00NoNoCurrent