FDA.reportPublic FDA data

HYDRALAZINE HYDROCHLORIDE

Product NDC
21695-680
11-digit product format
216950680
Labeler code
21695
Product ID
21695-680_d0a368ef-a524-4eb4-b984-5ee1d9d5a93d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA040901
Marketing category
ANDA
Marketing start
2008-09-12
Marketing end
0000-00-00
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
0284f4a6-db58-dacf-18fe-da73f4aeea88Product name420180827
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-680-302019-09-24C16284748780-1934fe258-4740-48b1-e053-8cdaa90a720aHYDRALAZINE HYDROCHLORIDE TABLETS, USP
21695-680-902019-09-24C16284748780-1934fe258-4740-48b1-e053-8cdaa90a720aHYDRALAZINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-680-30HYDRALAZINE HYDROCHLORIDE30 in 1 BOTTLETABLET302
21695-680-90HYDRALAZINE HYDROCHLORIDE90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-680-30EA - Each21695-6801714c3c5-8a2a-4dab-8a23-dc9ed45c770f12012-07-24
21695-680-90EA - Each21695-68057e46647-b6b6-4d39-a66c-4a10ee671ad312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hydralazine hydrochlorideACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
HydralazineACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
Anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKHYDRALAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDRALAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDRALAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
Stearic acidINACTIVE INGREDIENT4ELV7Z65APHYDRALAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-680HYDRALAZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2Legacy NDC, 2 package rows20111118_e9888fe1-a2ed-41b5-b5dd-df7fff3fad37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905199hydrALAZINE HCl 10 MG Oral TabletPSNe9888fe1-a2ed-41b5-b5dd-df7fff3fad372
905222hydrALAZINE HCl 100 MG Oral TabletPSNe9888fe1-a2ed-41b5-b5dd-df7fff3fad372
905225hydrALAZINE HCl 25 MG Oral TabletPSNe9888fe1-a2ed-41b5-b5dd-df7fff3fad372
905395hydrALAZINE HCl 50 MG Oral TabletPSNe9888fe1-a2ed-41b5-b5dd-df7fff3fad372
905199hydralazine hydrochloride 10 MG Oral TabletSCDe9888fe1-a2ed-41b5-b5dd-df7fff3fad372
905222hydralazine hydrochloride 100 MG Oral TabletSCDe9888fe1-a2ed-41b5-b5dd-df7fff3fad372
905225hydralazine hydrochloride 25 MG Oral TabletSCDe9888fe1-a2ed-41b5-b5dd-df7fff3fad372
905395hydralazine hydrochloride 50 MG Oral TabletSCDe9888fe1-a2ed-41b5-b5dd-df7fff3fad372

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-680-302169506803030 in 1 BOTTLEHistorical
21695-680-902169506809090 in 1 BOTTLEHistorical