FDA.reportPublic FDA data

NDC 68084-072-11 - 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
68084-072
Requested NDC
68084-072-11
Package NDCs from labels
68084-072-11, 68084-072-01
Manufacturer
American Health Packaging
Effective date
2018-12-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metformin Hydrochloride - American Health PackagingAmerican Health Packaging2018-12-20HUMAN 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
68084-072-01EA - Each68084-072a2d8f83e-ac04-4da0-b706-564fb2d4010312012-07-24
68084-072-11EA - Each68084-072c19665fe-7f5e-480c-8d59-a82916ec52f312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]5
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]5

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 10 of 49 · 964 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.a58ff524-e975-4d51-a896-e869f8ea66242026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackbe023bca-511e-4801-bd2b-e30dd14087722026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.c284c146-436b-4eea-9dca-d7d21c82778c2026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECoupler LLC51285096-e2ce-0f3c-e063-6394a90a35d42026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
DentastatALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, SILICEA, ZINCUM METALLICUM, PLATINUM METALLICUMEnergique, Inc.12786efd-df42-4321-bfdf-88f542d387bb2026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Age Defiance Pro7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATE, CALCAREA CARBONICA, CONIUM MACULATUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYDROFLUORICUM ACIDUM, HYPOPHYSIS SUIS, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, SILICEA, HUMAN GROWTH HORMONEEnergique, Inc.d528bdbe-fb75-4b13-9cbc-efa2177d74d82026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Pollen HayfeverADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM IODATUM, MUGWORT POLLEN (ARTEMISIA VULGARIS), BELLIS PERENNIS, BRASSICA SPP, CHENOPODIUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, ALFALFA POLLEN (MEDICAGO SATIVA), PHLEUM PRATENSE, YELLOW DOCK POLLEN (RUMEX CRISPUS), SABADILLA, SILICEA, GOLDENROD POLLEN (SOLIDAGO CANADENSIS), DANDELION POLLEN (TARAXACUM OFFICINALE), RED CLOVER POLLEN (TRIFOLIUM PRATENSE), XANTHIUM STRUMARIUMNaturalCare00665933-176e-4f16-b6ee-b55217b8abb32026-05-05WarningsExact identifier
unii: ETJ7Z6XBU4
MetforminMETFORMINREMEDYREPACK INC.27f603ec-25e6-4270-a7a3-34a64a76f7ef2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MetforminMETFORMIN ER 500 MGGranules Pharmaceuticals Inc.6d6ee6f8-9650-ff4f-e053-2991aa0acf192026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Hydrate ICOFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEABioActive Nutritional, Inc.c0c8d350-0257-4484-acd8-f852350173db2026-04-30WarningsExact identifier
unii: ETJ7Z6XBU4
MetforminMETFORMINIngenus Pharmaceuticals, LLC49a0b5c2-ebaf-4c4c-905f-dfd1962ac6472026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEGranules Pharmaceuticals Inc.2387a618-24d8-4813-aa83-9114edb353742026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs0448c618-2f0d-4ed3-866f-74b413cf902d2026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
DentastatALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, PALLADIUM METALLICUM, PHOSPHORUS, SILICEA, TITANIUM METALLICUM, ZINCUM METALLICUM, PLATINUM METALLICUM, PYROGENIUMEnergique, Inc.7f6d360b-9fee-4374-a47c-847806d54fa02026-04-13WarningsExact identifier
unii: ETJ7Z6XBU4
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
unii: 3NXW29V3WO
Animal Hair and DanderADRENALINUM, ALLIUM CEPA, ARSENICUM IODATUM, CAT (DANDER), DOG (DANDER), EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, SABADILLA, SHEEP WOOL, SILICEANaturalCaref0067255-9310-43a0-b415-c03a0f554bcc2026-04-10WarningsExact identifier
unii: ETJ7Z6XBU4
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.f94a10bd-1c40-42c7-b458-b580706145492026-04-10WarningsExact identifier
unii: ETJ7Z6XBU4
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.1467111a-bef6-473d-b7f2-3309a9bb72ce2026-04-10WarningsExact identifier
unii: ETJ7Z6XBU4
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDENovadoz Pharmaceuticals LLC4f890458-be94-4baf-b606-83a097e1e23e2026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPrecision Dose, Inc.60142fb2-16da-4f54-a542-74f9a70b9c8b2026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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