FDA.reportPublic FDA data

NDC 69238-2126-01 - 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
69238-2126
Requested NDC
69238-2126-01
Package NDCs from labels
69238-2126-3, 69238-2126-9, 69238-2126-1, 69238-2126-5, 69238-2126-01
Manufacturer
Amneal Pharmaceuticals LLC
Effective date
2026-07-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metformin Hydrochloride - Amneal Pharmaceuticals LLCAmneal Pharmaceuticals LLC2026-07-01HUMAN PRESCRIPTION DRUG LABEL
Metformin Hydrochloride - AvKAREAvKARE2026-05-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-2126-1Metformin Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
69238-2126-3Metformin Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE305
69238-2126-5Metformin Hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE5005
69238-2126-9Metformin Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2126METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS NY LLC]4Current NDC, Legacy NDC, 4 package rows20231128_dc65065b-cba0-46d7-8fb5-3368f3210b4d.zip

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 27 · 534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glipizide and Metformin HydrochlorideGLIPIZIDE AND METFORMIN HYDROCHLORIDEA-S Medication Solutions4a2d814b-93a1-4487-b789-dbafe9f0ffd32026-03-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Gout Symptom ReliefAMMON PHOS, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA AND URTICA URENS.King Bio Inc.41dc03fc-169b-4691-bd62-9a41d7a6d2f72026-03-06WarningsExact identifier
unii: 45P3261C7T
BEST SMELLING SALTSAMMONIUM CHLORIDE, SODIUM CARBONATE INHALANTHyvia Health LLC4c5cde0c-1de7-ce67-e063-6394a90a95792026-03-06WarningsExact identifier
unii: 45P3261C7T
Good Mood EnhancerAGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CALCAREA CARBONICA, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, IGNATIA AMARA, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SEPIA, SINAPIS ARVENSIS, FLOS AND TABACUM.King Bio Inc.26150aa1-7729-4f64-a761-eab251f046e52026-03-06WarningsExact identifier
unii: 45P3261C7T
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEdirect rxc33e24e9-0441-6b94-e053-2a95a90a9c682026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
PneumoforceALTHAEA OFFICINALIS, NATRUM CARBONICUM, RHEUM (PALMATUM), VERBASCUM THAPSUS, ZINGIBER OFFICINALE, ACONITUM NAPELLUS, DROSERA (ROTUNDIFOLIA), KALI BICHROMICUM, LOBELIA INFLATA, PHOSPHORUSBioActive Nutritional, Inc.a58c6a1a-ad3e-4055-8077-b6738105087d2026-03-05WarningsExact identifier
unii: 45P3261C7T
Total Body DetoxALUMINA, BRYONIA, CALCAREA IODATA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MAR, CHELIDONIUM MAJ, CINCHONA OFFICINALIS, CYNARA SCOLYMUS, DIOSCOREA VILLOSA, HEPAR SULPHURIS CALCAREUM, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, KALI IODATUM, MERCURIUS CORROSIVUS, MERCURIUS VIVUS, NATRUM CARBONICUM, NUX VOMICA, PLUMBUM METALLICUM, PTELEA TRIFOLIATA, RICINUS COMMUNIS, ROBINIA PSEUDOACACIA, SERUM ANGUILLAE, SOLIDAGO VIRGAUREA, SULPHUR, SULPHURICUM ACIDUM AND TARAXACUM OFFICINALE.King Bio Inc.c803733e-b5e2-46f2-bdfe-b239f38d93122026-03-04WarningsExact identifier
unii: 45P3261C7T
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEA-S Medication Solutionsf43c087a-7135-4a79-8463-fe5e9319da912026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions75b25738-31e6-4b58-9d2b-f4a1ab4ab0902026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 860975
unii: 786Z46389E
Focus, Comprehension and LearningAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, CALCAREA CARBONICA, IGNATIA AMARA, LECITHIN, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, OLEANDER, PHOSPHORICUM ACIDUM, RNA AND ZINCUM METALLICUM.King Bio Inc.b2a4dd82-7dd4-4dff-8a03-770f524bce1f2026-03-02WarningsExact identifier
unii: 45P3261C7T
Metformin Hydrochloride Oral SolutionMETFORMIN HYDROCHLORIDEBionpharma Inc.,3ab005d4-bc99-4fdb-e063-6394a90a51242026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMethod Pharmaceuticals, LLC.4aa880a4-7ec0-9155-e063-6394a90a8f3e2026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEA-S Medication Solutionsd87dade1-55fe-4e77-91b9-b642022a2b8a2026-02-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: FZ989GH94E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions239834b0-121a-4903-b3ee-90bb4db4753b2026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions5f2023d2-05ae-489d-9e18-fb75057496bc2026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
unii: FZ989GH94E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions1d7556eb-82b4-4085-b0b1-dc061b216feb2026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEQuallent Pharmaceuticals Health LLC6864ff5a-7512-4a4f-ad26-b2b9c58434142026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 860975
rxcui: 860981
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions8c248958-6c01-455e-89f5-959facb272ed2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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