NDC 68382-758-30 - 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
68382-758
Requested NDC
68382-758-30
Package NDCs from labels
68382-758-16, 68382-758-01, 68382-758-05, 68382-758-10, 68382-758-30, 68382-758-77
Manufacturer
Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited
Effective date
2026-07-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
METFORMIN - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2026-07-15HUMAN PRESCRIPTION DRUG LABEL
Metformin Hydrochloride - American Health PackagingAmerican Health Packaging2024-10-04HUMAN PRESCRIPTION DRUG LABEL
METFORMIN HYDROCHLORIDE - Legacy Pharmaceutical Packaging, LLCLegacy Pharmaceutical Packaging, LLC2020-12-01HUMAN PRESCRIPTION DRUG LABEL
METFORMIN HYDROCHLORIDE - A-S Medication SolutionsA-S Medication Solutions2018-08-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-758-01METFORMIN HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED10015
68382-758-05METFORMIN HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED50015
68382-758-10METFORMIN HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED100015
68382-758-16METFORMIN HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED9015
68382-758-30METFORMIN HYDROCHLORIDE1 in 1 BLISTER PACKTABLET, FILM COATED115
68382-758-77METFORMIN HYDROCHLORIDE100 in 1 CARTONTABLET, FILM COATED10015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-758METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]14Current NDC, Legacy NDC, 6 package rows20231110_c82a10fa-1e8e-46b6-890a-737de3f34ee1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-758-01EA - Each68382-75855d3f39f-fa4c-454c-860b-f3459fc25b3c12016-02-04
68382-758-05EA - Each68382-758278babf3-fa79-47b6-9553-261e87a0d0b212015-08-04
68382-758-10EA - Each68382-75853ae4a52-1541-463b-88ed-deaa60049f3b12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
GLYCERYL BEHENATEINACTIVE INGREDIENTR8WTH25YS2METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1

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 1 of 54 · 1,072 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.d5228e81-9c86-4781-b984-20feaa2ae7792026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MetforminMETFORMIN ER 500 MGREMEDYREPACK INC.05999192-ebc6-4198-bd1e-f46abbfb4f8a2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 860975
unii: 786Z46389E
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECamber Pharmaceuticals, Inc.7cc02a26-5c22-445b-ad8f-3e7570c143d32026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEGranules India Ltd73197cb5-3e23-4ac0-b189-f9bc848bce662026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutionsb6d7edc9-93d6-4480-906d-55c18d0536002026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
unii: 786Z46389E
Pioglitazone Hydrochloride and Metformin HydrochloridePIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEAurobindo Pharma Limited1fa2703e-fb73-44d5-aaa2-b12b1090d42c2026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Pioglitazone HCL and Metformin HCLPIOGLITAZONE HCL AND METFORMIN HCLTorrent Pharmaceuticals Limited237d8fa2-633c-4c29-84d3-f1b413610dc32026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions64f5b140-7ad8-4c07-bbfc-ae4618afa8502026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.bfd6ec0f-8264-4877-aa6d-f347f53bc4262026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.c568d49f-c040-4f1e-ad36-77b05ab659c32026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.ba0379cb-824e-4798-9ff9-99bcd1bea5cb2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackfb296500-55cb-45ce-be0c-59aa2e3d46242026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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