FDA.reportPublic FDA data

NDC 0228-2751-50 - Glyburide and Metformin 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
0228-2751
Requested NDC
0228-2751-50
Package NDCs from labels
0228-2751-11, 0228-2751-50
Manufacturer
Actavis Pharma, Inc.
Effective date
2020-05-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glyburide and Metformin Hydrochloride - Actavis Pharma, Inc.Actavis Pharma, Inc.2020-05-31HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-2751-11EA - Each0228-27510e0adb9f-7004-48e8-871b-431e71e34ee612012-07-24
0228-2751-50EA - Each0228-275149f1a08a-d6a6-40bf-be86-5be73372828412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYBURIDEACTIVE INGREDIENTSX6K58TVWCGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC]3
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC]3
GLYBURIDEACTIVE MOIETYSX6K58TVWCGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC]3
METFORMINACTIVE MOIETY9100L32L2NGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC]3
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)INACTIVE INGREDIENT5KY68S2577GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC]3
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC]3
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC]3
TRIACETININACTIVE INGREDIENTXHX3C3X673GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC]3

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 1 of 130 · 2,587 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.d5228e81-9c86-4781-b984-20feaa2ae7792026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MetforminMETFORMIN ER 500 MGREMEDYREPACK INC.05999192-ebc6-4198-bd1e-f46abbfb4f8a2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECamber Pharmaceuticals, Inc.7cc02a26-5c22-445b-ad8f-3e7570c143d32026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEGranules India Ltd73197cb5-3e23-4ac0-b189-f9bc848bce662026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutionsb6d7edc9-93d6-4480-906d-55c18d0536002026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Pioglitazone Hydrochloride and Metformin HydrochloridePIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEAurobindo Pharma Limited1fa2703e-fb73-44d5-aaa2-b12b1090d42c2026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Pioglitazone HCL and Metformin HCLPIOGLITAZONE HCL AND METFORMIN HCLTorrent Pharmaceuticals Limited237d8fa2-633c-4c29-84d3-f1b413610dc32026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions64f5b140-7ad8-4c07-bbfc-ae4618afa8502026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.bfd6ec0f-8264-4877-aa6d-f347f53bc4262026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
BMNP ALUMINUM OXIDEALUMINUM OXIDETotal Operations Management LLC DBA:Bestmade Natural Products Micro5a5ad83a-0ecb-21fa-e063-6294a90a14222026-08-31WarningsExact identifier
unii: LMI26O6933
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.c568d49f-c040-4f1e-ad36-77b05ab659c32026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.ba0379cb-824e-4798-9ff9-99bcd1bea5cb2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackfb296500-55cb-45ce-be0c-59aa2e3d46242026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
SynjardyEMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.0fdd0255-0055-65f3-b2c0-db8fbb87beae2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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