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 9 of 50 · 996 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GUNA-AWARENESSBETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE - SUS SCROFA FRONTAL LOBE - SUS SCROFA TEMPORAL LOBE - THYROTROPIN ALFA - UBIDECARENONE - VANADIUM - ZINC - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN -Guna spa10e46b39-7903-4390-b72d-865291245b4c2026-06-10WarningsExact identifier
unii: ETJ7Z6XBU4
Metformin HydrochlorideMETFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETSQingdao BAHEAL Pharmaceutical Co. Ltd.7ea6e623-4073-4671-e053-2a91aa0a3ca32026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
glyburide and metformin hydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limiteddf752bd4-e197-40a4-a01b-d48ba2c105162026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited53d1c51a-77eb-bb3c-e063-6394a90aab3f2026-06-09WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO18CALC FLUOR, CALC SULF, SILICEA.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d3c1d6-d0ba-5ea7-e063-6394a90a02942026-06-09WarningsExact identifier
unii: ETJ7Z6XBU4
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMARKSANS PHARMA LIMITEDb8004451-7b26-425b-b5ea-cbb1b08e30e32026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEQPharma Inc5269e91f-7e93-9405-e063-6294a90a32172026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
BM SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro53bb3927-6053-eb3d-e063-6394a90a5ddf2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEQPharma Inc53bde438-4277-f418-e063-6394a90a5ea22026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
ScrofularoforceRUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANABioActive Nutritional, Inc.737cd410-0405-41b0-b7f2-29bb200378492026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
VAXBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA,BioActive Nutritional, Inc.faa4a678-321a-4982-a5d4-01b713e6862d2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMylan Pharmaceuticals Inc.4f70f907-08d5-4c2e-a4be-32c6124faa7b2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
VermexARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUMBioActive Nutritional, Inc.6be5fbcf-bb22-4b20-b65a-d943c516adf92026-06-04WarningsExact identifier
unii: ETJ7Z6XBU4
BM Silicea Icing SugarSILICEA ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro535ba100-627f-36b4-e063-6394a90a33732026-06-03WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEABM Private Limited5331dc40-2ac8-5fce-e063-6394a90a58752026-06-01WarningsExact identifier
unii: ETJ7Z6XBU4
Metformin HClMETFORMIN HCLProficient Rx LPd2c927eb-12bf-4c7d-9ef5-0036b2dd8c292026-06-01Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.d1d7204a-7e8a-4f76-bf9f-3e798c2632ba2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEWestminster Pharmaceuticals, LLC836f3647-bfef-40d1-b475-c0d240241a672026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack1e7ab8da-4ece-499c-b0fb-34e37d991c1c2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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