FDA.reportPublic FDA data

NDC 65841-809-30 - 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
65841-809
Requested NDC
65841-809-30
Package NDCs from labels
65841-809-16, 65841-809-01, 65841-809-05, 65841-809-10, 65841-809-30, 65841-809-77
Manufacturer
Zydus Lifesciences Limited
Effective date
2024-12-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
METFORMIN HYDROCHLORIDE - Zydus Lifesciences LimitedZydus Lifesciences Limited2024-12-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-809-01METFORMIN HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED10014
65841-809-05METFORMIN HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED50014
65841-809-10METFORMIN HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED100014
65841-809-16METFORMIN HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED9014
65841-809-30METFORMIN HYDROCHLORIDE1 in 1 BLISTER PACKTABLET, FILM COATED114
65841-809-77METFORMIN HYDROCHLORIDE100 in 1 CARTONTABLET, FILM COATED10014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-809METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]14Current NDC, Legacy NDC, 6 package rows20241207_5043d03e-3c9d-4c96-b48d-187f02a1d27c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]4
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]4
GLYCERYL BEHENATEINACTIVE INGREDIENTR8WTH25YS2METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]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 33 of 53 · 1,053 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HClMETFORMIN HCLNuCare Pharmaceuticals,Inc.0b3d7c79-9a5a-a82e-e063-6394a90a3caa2025-02-03Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEProficient Rx LPf1530d4f-21d9-4a4f-a814-07b180828ecd2025-02-01WarningsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP7cb47c3e-6657-4c11-8aa2-ae172e5a85292025-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 860975
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDELifsa Drugs, LLCa2385bcd-0943-4411-8658-c22b503603852025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d63b107-cd47-d9a5-e053-2a95a90a44932025-01-28WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM55DAPHNE INDICA, NATRUM PHOS, SILICA MARINA, TABACUMBestmade Natural Products2c751942-5b36-8558-e063-6294a90af87a2025-01-24WarningsExact identifier
unii: ETJ7Z6XBU4
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d626292-7abb-1afb-e053-2995a90a28182025-01-24WarningsExact identifier
unii: ETJ7Z6XBU4
Metformin HydrochlorideMETFORMIN HYDROCHLORIDERedPharm Drug, Inc.fc61bafa-a506-14ae-e053-6394a90a9c7d2025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 860975
unii: 786Z46389E
DOCTRUST K ToothSILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATEDOCSMEDI Co., Ltd.a02f8865-e7be-4ef4-b09c-dad8466397642025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products Bio4CALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Productsea224687-106e-3821-e053-2995a90aa69c2025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEdirect rxa84cf1a3-3820-cd1b-e053-2995a90acf452025-01-22WarningsExact identifier
rxcui: 860975
unii: 786Z46389E
Bestmade Natural Products BM5APIS MELD3, BAPTISIAD4, CONIUM MACD8, ECHINACEAD2, EUPATORIUMD4, SILICEAD6, THUJA OCCD8Bestmade Natural Productsebdcb53e-1767-cd08-e053-2995a90aedeb2025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products Bio18CALC FLUOR, SILICEA, CALC SULPHBestmade Natural Productseac337aa-11a1-5b17-e053-2a95a90ad19d2025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
Lemon QuinceLEMON QUINCEUriel Pharmacy Inc332e4a40-e0f3-11de-8a39-0800200c9a662025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.4adeddf2-f449-4a61-9658-dfbff7c502302025-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 860975
unii: 786Z46389E
Hydration ComplexBETA VULGARIS, BOLDO, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARDUUS BENEDICTUS, CHELIDONIUM MAJUS, COFFEA TOSTA, EQUISETUM ARVENSE, GERMANIUM SESQUIOXIDE, GINKGO BILOBA, HYPERICUM PERFORATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, PETROSELINUM SATIVUM, SILICEA, TARAXACUM OFFICINALEDeseret Biologicals, Inc.f60a2ab8-4146-4995-9bc6-be2660b175402025-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
Metformin hydrochloride ERMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC27d6fdbc-27a8-c599-e063-6394a90a22332025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.0f251f2c-97f3-4048-84f2-81fea03685aa2025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
D-34OYSTER SHELL CALCIUM CARBONATE, CRUDE, CALCIUM FLUORIDE, CALCIUM HYPOPHOSPHITE, TRIBASIC CALCIUM PHOSPHATE, HEKLA LAVA, DAPHNE MEZEREUM BARK, MERCURIC OXIDE, SILICON DIOXIDE, AND MATRICARIA CHAMOMILLADNA Labs, Inc.607e21a3-2229-48fa-b12c-ebd3130b99962025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-33ATROPA BELLADONNA, BUFO BUFO CUTANEOUS GLAND, COPPER, ANEMONE PRATENSIS, SILICON DIOXIDE, AND ZINCDNA Labs, Inc.26f9bf6d-6038-42e8-b8c1-6c94ac4929af2025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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