FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
17478-934
11-digit product format
174780934
Labeler code
17478
Product ID
17478-934_202642d1-3384-4cc6-8831-e2b35a6812e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Akorn
Application
ANDA040730
Marketing category
ANDA
Marketing start
2009-05-01
Marketing end
0000-00-00
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3137695-e199-b3b3-2950-87a8ac429689Product name520260316
e9ed2ee5-d109-4795-bffe-c3b047717749Product name220250107
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
0284f4a6-db58-dacf-18fe-da73f4aeea88Product name420180827
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17478-934-012024-01-30C16284748780-11030e364-f9c9-111a-e063-dadaa90a10e2HydrALAZINE Hydrochloride Injection
17478-934-102024-01-30C16284748780-11030e364-f9c9-111a-e063-dadaa90a10e2HydrALAZINE Hydrochloride Injection
17478-934-152024-01-30C16284748780-11030e364-f9c9-111a-e063-dadaa90a10e2HydrALAZINE Hydrochloride Injection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-934-01Hydralazine Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION114
17478-934-10Hydralazine Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION114
17478-934-10Hydralazine Hydrochloride10 in 1 CARTONINJECTION1014
17478-934-15Hydralazine Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION114
17478-934-15Hydralazine Hydrochloride25 in 1 CARTONINJECTION2514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-934-01ML - Milliliter17478-9346ace9bcf-09ca-4b72-85f4-faa9d955a8c112012-07-24
17478-934-10ML - Milliliter17478-934020bb0f2-db20-4903-871e-1938116b3e5f12022-07-06
17478-934-15ML - Milliliter17478-9349f2483eb-6a9a-4743-84ce-80e9804f4add12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hydralazine HydrochlorideACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.]5
HydralazineACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.]5
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBHYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.]5
MethylparabenINACTIVE INGREDIENTA2I8C7HI9THYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.]5
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3HYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.]5
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHHYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.]5
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IHYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.]5
WaterINACTIVE INGREDIENT059QF0KO0RHYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.]5
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBHYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-934HYDRALAZINE HYDROCHLORIDE INJECTION [AKORN]14Legacy NDC, 5 package rows20220914_e31239e0-8c5a-4d10-9404-af32278484a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSNe31239e0-8c5a-4d10-9404-af32278484a314
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCDe31239e0-8c5a-4d10-9404-af32278484a314
966571hydralazine HCl 20 MG per 1 ML InjectionSYe31239e0-8c5a-4d10-9404-af32278484a314
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSN94530e4d-b1c0-6171-e053-2a95a90a05fa4
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCD94530e4d-b1c0-6171-e053-2a95a90a05fa4
966571hydralazine HCl 20 MG per 1 ML InjectionSY94530e4d-b1c0-6171-e053-2a95a90a05fa4
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSN04b4c1c2-093c-4f48-a6b4-3e290fae51b41
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCD04b4c1c2-093c-4f48-a6b4-3e290fae51b41
966571hydralazine HCl 20 MG per 1 ML InjectionSY04b4c1c2-093c-4f48-a6b4-3e290fae51b41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17478-934-011747809340110 VIAL, SINGLE-DOSE in 1 CARTON (17478-934-01) > 1 mL in 1 VIAL, SINGLE-DOSE2009-05-010000-00-00NoNoCurrent
17478-934-101747809341010 VIAL, SINGLE-DOSE in 1 CARTON (17478-934-10) > 1 mL in 1 VIAL, SINGLE-DOSE2009-05-010000-00-00NoNoCurrent
17478-934-151747809341525 VIAL, SINGLE-DOSE in 1 CARTON (17478-934-15) > 1 mL in 1 VIAL, SINGLE-DOSE2009-05-010000-00-00NoNoCurrent