FDA.reportPublic FDA data

NDC 65841-810-30 - 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
65841-810
Requested NDC
65841-810-30
Package NDCs from labels
65841-810-16, 65841-810-01, 65841-810-05, 65841-810-10, 65841-810-30, 65841-810-77
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
65841-810-01METFORMIN HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED10014
65841-810-05METFORMIN HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED50014
65841-810-10METFORMIN HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED100014
65841-810-16METFORMIN HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED9014
65841-810-30METFORMIN HYDROCHLORIDE1 in 1 BLISTER PACKTABLET, FILM COATED114
65841-810-77METFORMIN HYDROCHLORIDE100 in 1 CARTONTABLET, FILM COATED10014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-810METFORMIN 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 40 of 52 · 1,021 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VerARTEMISIA VULGARIS, ASCARIS LUMBRICOIDES, BRUGIA MALAYI, CALCAREA CARBONICA, CINA, CRYPTOSPORIDIUM PARVUM, ENTEROBIUS VERMICULARIS, FILIX MAS, GIARDIA LAMBLIA, GRAPHITES, IODIUM, MERCURIUS CORROSIVUS, QUASSIA (AMARA), SABADILLA, SILICEA, SPIGELIA ANTHELMIA, TAENIA SAGINATA, TAENIA SOLIUM, TEUCRIUM MARUM, THYMUS SERPYLLUM, TRICHINELLA SPIRALIS, TRICHOMONAS VAGINALISDeseret Biologicals, Inc.b47bdd57-14cd-46e9-a34e-0d8a7c21bda22024-03-12WarningsExact identifier
unii: ETJ7Z6XBU4
ElevateLYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SEPIA, CAUSTICUM, PHOSPHORUS, SULPHUR, 5-HYDROXYTRYPTOPHAN, ALUMINA, SILICEA, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, NOREPINEPHRINE (BITARTRATE), PHENYLETHYLAMINE (HYDROCHLORIDE), SEROTONIN (HYDROCHLORIDE), ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM (SUIS), DIENCEPHALON (SUIS), FUNICULUS UMBILICALIS SUIS, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, FAECALIS (ALKALIGENES), GAERTNER BACILLUS (BACH), PROTEUS (VULGARIS)Deseret Biologicals, Inc.5c0ff0d8-2db4-42c0-9b6d-572f9ad0c98b2024-03-11WarningsExact identifier
unii: ETJ7Z6XBU4
SpinalmaxBERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS (SUIS), PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUMDeseret Biologicals, Inc.6c569331-2167-44bb-ace6-13340e7d8d6a2024-03-11WarningsExact identifier
unii: ETJ7Z6XBU4
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepackd5dbf0d9-9673-4aae-9e28-da9b90bac0382024-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsc2783b59-7b20-4d4c-a3ca-03ed60dcf2c32024-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions2be73d5e-7682-4ad3-831b-8c1ea73e38de2024-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
unii: 786Z46389E
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH), L-TRYPTOPHAN, MELATONIN, MERCURIUS CORROSIVUS, PANTOTHENIC ACID, PASSIFLORA INCARNATA, PINEAL GLAND (SUIS), PYRROLE, SARCOLACTICUM ACIDUM, SILICEA, UBIDECARENONUM, ZINCUM VALERIANICUMDeseret Biologicals, Inc.81f29472-a2e6-486d-aefd-17135ad410ef2024-03-08WarningsExact identifier
unii: ETJ7Z6XBU4
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP928ef685-80cb-42a9-a155-3c21c9b1dd672024-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
Kidney DrainageSOLIDAGO VIRGAUREA, ASPARAGUS OFFICINALIS, JUNIPERUS COMMUNIS, SABAL SERRULATA, UVA-URSI, BERBERIS VULGARIS, EQUISETUM ARVENSE, URTICA DIOICA, RUBIA TINCTORUM, STAPHYSAGRIA, CANTHARIS, FAGUS SYLVATICA, FLOS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUM, KIDNEY (SUIS), LARIX DECIDUA, FLOS, MANGANUM METALLICUM, MIMULUS GUTTATUS, FLOS, NITRICUM ACIDUM, RHUS AROMATICA, SILICEA, ULEX EUROPAEUS, FLOS, BENZOICUM ACIDUM, COBALTUM METALLICUMDeseret Biologicals, Inc.a030afc6-9248-4e6a-a814-bd700c053e5c2024-02-20WarningsExact identifier
unii: ETJ7Z6XBU4
CoughIPECACUANHA, STICTA PULMONARIA, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, ACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, SILICEA, TABACUM, PERTUSSINUM, TETANUS TOXINDeseret Biologicals, Inc.4a8deb4a-9f26-46a9-8d99-99df36407f222024-02-19WarningsExact identifier
unii: ETJ7Z6XBU4
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.1182bf60-3578-a0ed-e063-6394a90aa50f2024-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
unii: 786Z46389E
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)Deseret Biologicals, Inc.6d934960-63c6-4536-bde3-38c26f8083dc2024-02-06WarningsExact identifier
unii: ETJ7Z6XBU4
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack9c33414b-5dbb-4ce9-910b-9480d45e50ee2024-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepackf9e78e0f-6a0a-4db3-bc09-5500748f9c842024-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
GOODSENSE ARTIFICIAL TEARSPOLYVINYL ALCOHOLProficient Rx LPf29c792c-6cb2-449f-b97d-6304a58dec2a2024-02-01WarningsExact identifier
unii: FZ989GH94E
GoodSense Artifical TearsPOLYVINYL ALCOHOL, AND POVIDONEProficient Rx LPcd24da78-fd90-4a9c-8e5f-f7fc56ec0fc92024-02-01WarningsExact identifier
unii: FZ989GH94E
SiliceaSILICON DIOXIDESEVENE USA0805d866-ce1a-4f54-8a44-83d4902e8c0d2024-01-30WarningsExact identifier
unii: ETJ7Z6XBU4
GENTEAL TEARSDEXTRAN 70, GLYCERIN, HYPROMELLOSEA-S Medication Solutionsa2b715e9-332d-4f0b-b8e5-ebc0006815862024-01-21WarningsExact identifier
unii: 3NXW29V3WO
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions3c607f04-d36f-4cf8-9cc9-7f2af08b40982024-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Sleep TightADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)Dr. Donna Restivo DCb5955fbc-71f8-4fe0-9df0-42f337ab9c7d2024-01-18WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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