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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd9892176-d4a6-4edb-92b9-5f56243f3d222016-06-13Warnings, Adverse reactionsExact identifier
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.ddbbdb09-3202-42d7-bbb0-08331dde2f542016-02-29Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
rxcui: 905222
unii: FD171B778Y
d0a368ef-a524-4eb4-b984-5ee1d9d5a93de9888fe1-a2ed-41b5-b5dd-df7fff3fad372011-01-17Warnings, Adverse reactionsExact identifier
spl id: d0a368ef-a524-4eb4-b984-5ee1d9d5a93d
spl set id: e9888fe1-a2ed-41b5-b5dd-df7fff3fad37
46F13307-7260-0715-CC8E-679B585D85FAa2b73026-2451-406f-b866-9dc16177cb442008-09-19Warnings, Adverse reactionsExact identifier
spl id: 46F13307-7260-0715-CC8E-679B585D85FA
spl set id: a2b73026-2451-406f-b866-9dc16177cb44

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.