FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
70710-1988
11-digit product format
707101988
Labeler code
70710
Product ID
70710-1988_080a71a3-1d50-42bf-b329-bf64a84893d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA202938
Marketing category
ANDA
Marketing start
2025-04-28
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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 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
70710-1988-1Hydralazine Hydrochloride1 mL in 1 VIALINJECTION12
70710-1988-7Hydralazine Hydrochloride25 in 1 PACKAGEINJECTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1988-1ML - Milliliter70710-1988e93307f2-e83d-4b1d-95cc-21570d338a6012025-10-14
70710-1988-7ML - Milliliter70710-1988722ff91f-3d9c-4b91-9112-a284d6d12a0a12025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1988HYDRALAZINE HYDROCHLORIDE INJECTION [ZYDUS PHARMACEUTICALS USA INC.]1Current NDC, 2 package rows20250429_f0db9c3c-d841-46f9-8409-9ffca83d7a97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSNf0db9c3c-d841-46f9-8409-9ffca83d7a972
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCDf0db9c3c-d841-46f9-8409-9ffca83d7a972
966571hydralazine HCl 20 MG per 1 ML InjectionSYf0db9c3c-d841-46f9-8409-9ffca83d7a972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1988-1707101988011 mL in 1 VIAL1 mlHistorical
70710-1988-77071019880725 VIAL in 1 PACKAGE (70710-1988-7) / 1 mL in 1 VIAL (70710-1988-1) 25 vial2025-04-28NoNoHistorical