FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
31722-521
11-digit product format
317220521
Labeler code
31722
Product ID
31722-521_30381b85-deb3-bc70-e063-6294a90ad921
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA040901
Marketing category
ANDA
Marketing start
2010-01-01
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, 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
31722-521-01Hydralazine Hydrochloride100 in 1 BOTTLETABLET1005
31722-521-05Hydralazine Hydrochloride500 in 1 BOTTLETABLET5005
31722-521-10Hydralazine Hydrochloride1000 in 1 BOTTLETABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-521-01EA - Each31722-5215c37f60f-b561-4ea3-85a3-9fb428f8c49112012-07-24
31722-521-10EA - Each31722-521d2d48db7-8db0-42c6-bbdf-dba7fdd71b5d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS]1
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS]1
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDRALAZINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDRALAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDRALAZINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDRALAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDRALAZINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDRALAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDRALAZINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDRALAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-521HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 3 package rows20250316_5da36930-d3da-4b5c-9e22-2b141bc01a9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905395hydrALAZINE HCl 50 MG Oral TabletPSN90c18c55-3045-4a10-a2bb-012e4a5e15641008
905395hydralazine hydrochloride 50 MG Oral TabletSCD90c18c55-3045-4a10-a2bb-012e4a5e15641008
905225hydrALAZINE HCl 25 MG Oral TabletPSNf16f1d87-f9e6-4555-9baf-26ff17cb1d2831
905395hydrALAZINE HCl 50 MG Oral TabletPSNf16f1d87-f9e6-4555-9baf-26ff17cb1d2831
905225hydralazine hydrochloride 25 MG Oral TabletSCDf16f1d87-f9e6-4555-9baf-26ff17cb1d2831
905395hydralazine hydrochloride 50 MG Oral TabletSCDf16f1d87-f9e6-4555-9baf-26ff17cb1d2831
905199hydrALAZINE HCl 10 MG Oral TabletPSN5da36930-d3da-4b5c-9e22-2b141bc01a9c5
905222hydrALAZINE HCl 100 MG Oral TabletPSN5da36930-d3da-4b5c-9e22-2b141bc01a9c5
905225hydrALAZINE HCl 25 MG Oral TabletPSN5da36930-d3da-4b5c-9e22-2b141bc01a9c5
905395hydrALAZINE HCl 50 MG Oral TabletPSN5da36930-d3da-4b5c-9e22-2b141bc01a9c5
905199hydralazine hydrochloride 10 MG Oral TabletSCD5da36930-d3da-4b5c-9e22-2b141bc01a9c5
905222hydralazine hydrochloride 100 MG Oral TabletSCD5da36930-d3da-4b5c-9e22-2b141bc01a9c5
905225hydralazine hydrochloride 25 MG Oral TabletSCD5da36930-d3da-4b5c-9e22-2b141bc01a9c5
905395hydralazine hydrochloride 50 MG Oral TabletSCD5da36930-d3da-4b5c-9e22-2b141bc01a9c5
905395hydrALAZINE HCl 50 MG Oral TabletPSN4b7d3378-86f8-0a5f-e054-00144ff8d46c4
905395hydralazine hydrochloride 50 MG Oral TabletSCD4b7d3378-86f8-0a5f-e054-00144ff8d46c4
905395hydrALAZINE HCl 50 MG Oral TabletPSNcba6a3d1-f76b-9adc-e053-2995a90aaad43
905395hydralazine hydrochloride 50 MG Oral TabletSCDcba6a3d1-f76b-9adc-e053-2995a90aaad43
905395hydrALAZINE HCl 50 MG Oral TabletPSN7253aaa0-e272-499f-9bfa-304e9556a8fb1
905395hydrALAZINE HCl 50 MG Oral TabletPSN2c65df39-26d8-4428-8306-d43cbfcaf1621
905395hydrALAZINE HCl 50 MG Oral TabletPSN2669b843-9337-78bb-e063-6394a90aba191
905395hydralazine hydrochloride 50 MG Oral TabletSCD2669b843-9337-78bb-e063-6394a90aba191
905395hydralazine hydrochloride 50 MG Oral TabletSCD7253aaa0-e272-499f-9bfa-304e9556a8fb1
905395hydralazine hydrochloride 50 MG Oral TabletSCD2c65df39-26d8-4428-8306-d43cbfcaf1621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-521-0131722052101100 TABLET in 1 BOTTLE (31722-521-01) 100 tablet2010-01-010000-00-00NoNoCurrent
31722-521-0531722052105500 TABLET in 1 BOTTLE (31722-521-05) 500 tablet2010-01-010000-00-00NoNoCurrent
31722-521-10317220521101000 TABLET in 1 BOTTLE (31722-521-10) 1000 tablet2010-01-010000-00-00NoNoCurrent