FDA.reportPublic FDA data

NDC 65977-220 - HYDRALAZINE HYDROCHLORIDE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
65977-220
Package NDCs from labels
65977-220-10, 65977-220-50, 65977-220-01
Manufacturer
Rebel Distributors Corp
Effective date
2011-01-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HYDRALAZINE HYDROCHLORIDE - Rebel Distributors CorpRebel Distributors Corp2011-01-17HUMAN PRESCRIPTION DRUG LABEL
HYDRALAZINE HYDROCHLORIDE - HETERO DRUGS LIMITEDHETERO DRUGS LIMITED2008-09-19HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65977-220-01HYDRALAZINE HYDROCHLORIDE1000 in 1 BOTTLETABLET10001
65977-220-10HYDRALAZINE HYDROCHLORIDE100 in 1 BOTTLETABLET1001
65977-220-50HYDRALAZINE HYDROCHLORIDE500 in 1 BOTTLETABLET5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65977-220HYDRALAZINE HYDROCHLORIDE TABLET [HETERO DRUGS LIMITED]13 package rows20081030_a2b73026-2451-406f-b866-9dc16177cb44.zip

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
Hydralazine hydrochlorideACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET [HETERO DRUGS LIMITED]1
HydralazineACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET [HETERO DRUGS LIMITED]1
Anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKHYDRALAZINE HYDROCHLORIDE TABLET [HETERO DRUGS LIMITED]1
FD&C Yellow # 6INACTIVE INGREDIENTHYDRALAZINE HYDROCHLORIDE TABLET [HETERO DRUGS LIMITED]1
Microcrystalline celluloseINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET [HETERO DRUGS LIMITED]1
Sodium starch glycolateINACTIVE INGREDIENTHYDRALAZINE HYDROCHLORIDE TABLET [HETERO DRUGS LIMITED]1
Stearic acidINACTIVE INGREDIENT4ELV7Z65APHYDRALAZINE HYDROCHLORIDE TABLET [HETERO DRUGS LIMITED]1