FDA.reportPublic FDA data

HydrALAZINE Hydrochloride

Product NDC
64380-733
11-digit product format
643800733
Labeler code
64380
Product ID
64380-733_4ca5f9d2-a4ec-4be1-865f-96a4615087b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HydrALAZINE Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA200770
Marketing category
ANDA
Marketing start
2022-06-30
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
2027-12-31

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
64380-733-06HydrALAZINE Hydrochloride100 in 1 BOTTLETABLET10012
64380-733-07HydrALAZINE Hydrochloride500 in 1 BOTTLETABLET50012
64380-733-08HydrALAZINE Hydrochloride1000 in 1 BOTTLETABLET100012

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]6
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDRALAZINE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDRALAZINE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDRALAZINE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDRALAZINE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-733HYDRALAZINE HYDROCHLORIDE TABLET [STRIDES PHARMA SCIENCE LIMITED]12Current NDC, Legacy NDC, 3 package rows20220701_b3d1786d-c3ff-42f1-a09f-37a9c9021e5a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-733-0664380073306100 TABLET in 1 BOTTLE (64380-733-06) 100 tablet2022-06-300000-00-00NoNoCurrent
64380-733-0764380073307500 TABLET in 1 BOTTLE (64380-733-07) 500 tablet2022-06-300000-00-00NoNoCurrent
64380-733-08643800733081000 TABLET in 1 BOTTLE (64380-733-08) 1000 tablet2022-06-300000-00-00NoNoCurrent