FDA.reportPublic FDA data

HydrALAZINE hydrochloride

Product NDC
0641-6231
11-digit product format
006416231
Labeler code
0641
Product ID
0641-6231_e0fe7653-bdb1-42fc-8277-fc07794f85d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HydrALAZINE hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA213667
Marketing category
ANDA
Marketing start
2020-12-18
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
20 mg/mL
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 HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFD171B778Y
Rxcui966571

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
0641-6231-01HydrALAZINE hydrochloride20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION202
0641-6231-25HydrALAZINE hydrochloride25 in 1 CARTONINJECTION, SOLUTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6231-01ML - Milliliter0641-62319926f261-4f08-4c40-881f-705a84720c4d12021-05-05
0641-6231-25ML - Milliliter0641-6231b0027ea1-addf-4d1b-86ed-fb39abf4093c12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6231HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]2Current NDC, Legacy NDC, 2 package rows20240411_3f5f1204-d289-40e9-be84-a29352f64bfb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSN3f5f1204-d289-40e9-be84-a29352f64bfb2
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSNd89d981d-64cf-7321-e053-2995a90aab4a2
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCD3f5f1204-d289-40e9-be84-a29352f64bfb2
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCDd89d981d-64cf-7321-e053-2995a90aab4a2
966571hydralazine HCl 20 MG per 1 ML InjectionSY3f5f1204-d289-40e9-be84-a29352f64bfb2
966571hydralazine HCl 20 MG per 1 ML InjectionSYd89d981d-64cf-7321-e053-2995a90aab4a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6231-010064162310120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
0641-6231-250064162312525 VIAL, SINGLE-DOSE in 1 CARTON (0641-6231-25) / 20 mL in 1 VIAL, SINGLE-DOSE (0641-6231-01) 2020-12-180000-00-00NoNoCurrent