FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
50228-184
11-digit product format
502280184
Labeler code
50228
Product ID
50228-184_bcb83203-049e-1ddd-e053-2a95a90ae336
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
Application
ANDA205236
Marketing category
ANDA
Marketing start
2017-05-26
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
50228-184-01Hydralazine Hydrochloride100 in 1 BOTTLETABLET1007
50228-184-10Hydralazine Hydrochloride1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-184-01EA - Each50228-184f4e67fcc-024d-4def-b71f-2342055c3a8712019-11-12
50228-184-10EA - Each50228-1841a01dc5c-2974-415a-8140-b2e918fcb83d12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-184HYDRALAZINE HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 2 package rows20210305_500b7f76-5f4e-4e7d-85c3-18b9f66d7504.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905395hydrALAZINE HCl 50 MG Oral TabletPSN18dd864f-1e27-4c98-8f21-eaded77a3ed6102
905395hydralazine hydrochloride 50 MG Oral TabletSCD18dd864f-1e27-4c98-8f21-eaded77a3ed6102
905395hydrALAZINE HCl 50 MG Oral TabletPSNd5b0165e-9823-470a-8ed0-5c4c8722369d100
905395hydrALAZINE HCl 50 MG Oral TabletPSN62475f78-5410-43c2-a11d-54a8363c3ae1100
905395hydralazine hydrochloride 50 MG Oral TabletSCD62475f78-5410-43c2-a11d-54a8363c3ae1100
905395hydralazine hydrochloride 50 MG Oral TabletSCDd5b0165e-9823-470a-8ed0-5c4c8722369d100
905199hydrALAZINE HCl 10 MG Oral TabletPSN500b7f76-5f4e-4e7d-85c3-18b9f66d75047
905222hydrALAZINE HCl 100 MG Oral TabletPSN500b7f76-5f4e-4e7d-85c3-18b9f66d75047
905225hydrALAZINE HCl 25 MG Oral TabletPSN500b7f76-5f4e-4e7d-85c3-18b9f66d75047
905395hydrALAZINE HCl 50 MG Oral TabletPSN500b7f76-5f4e-4e7d-85c3-18b9f66d75047
905199hydralazine hydrochloride 10 MG Oral TabletSCD500b7f76-5f4e-4e7d-85c3-18b9f66d75047
905222hydralazine hydrochloride 100 MG Oral TabletSCD500b7f76-5f4e-4e7d-85c3-18b9f66d75047
905225hydralazine hydrochloride 25 MG Oral TabletSCD500b7f76-5f4e-4e7d-85c3-18b9f66d75047
905395hydralazine hydrochloride 50 MG Oral TabletSCD500b7f76-5f4e-4e7d-85c3-18b9f66d75047
905395hydrALAZINE HCl 50 MG Oral TabletPSN8ade1ffe-3738-4aa1-b9c7-59f7290600b91
905395hydrALAZINE HCl 50 MG Oral TabletPSNa8194ac4-02d5-4aa1-b4e4-a3759f6f64b51
905395hydralazine hydrochloride 50 MG Oral TabletSCD8ade1ffe-3738-4aa1-b9c7-59f7290600b91
905395hydralazine hydrochloride 50 MG Oral TabletSCDa8194ac4-02d5-4aa1-b4e4-a3759f6f64b51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-184-0150228018401100 TABLET in 1 BOTTLE (50228-184-01) 100 tablet2017-05-260000-00-00NoNoCurrent
50228-184-10502280184101000 TABLET in 1 BOTTLE (50228-184-10) 1000 tablet2017-05-260000-00-00NoNoCurrent