NDC 59115-014-01 - Glyburide

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
59115-014
Requested NDC
59115-014-01
Package NDCs from labels
59115-014-01, 59115-014-05, 59115-014-99
Manufacturer
Hikma Pharmaceutical
Effective date
2015-02-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glyburide - Hikma PharmaceuticalHikma Pharmaceutical2015-02-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYBURIDEACTIVE INGREDIENTSX6K58TVWCGLYBURIDE TABLET [HIKMA PHARMACEUTICAL]4
GLYBURIDEACTIVE MOIETYSX6K58TVWCGLYBURIDE TABLET [HIKMA PHARMACEUTICAL]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLYBURIDE TABLET [HIKMA PHARMACEUTICAL]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLYBURIDE TABLET [HIKMA PHARMACEUTICAL]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLYBURIDE TABLET [HIKMA PHARMACEUTICAL]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLYBURIDE TABLET [HIKMA PHARMACEUTICAL]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GLYBURIDE TABLET [HIKMA PHARMACEUTICAL]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGLYBURIDE TABLET [HIKMA PHARMACEUTICAL]4

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 34 of 34 · 661 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f2e6f347-50f7-4f73-bb81-6ca39e66093cdc8541fe-2ca9-45e3-af96-c92e338b6df52015-02-11Warnings, Adverse reactionsExact identifier
spl id: f2e6f347-50f7-4f73-bb81-6ca39e66093c
spl set id: dc8541fe-2ca9-45e3-af96-c92e338b6df5

Reported adverse events (FAERS/openFDA)#

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