FDA.reportPublic FDA data

NDC 68382-655-30 - glyburide and 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
68382-655
Requested NDC
68382-655-30
Package NDCs from labels
68382-655-06, 68382-655-16, 68382-655-01, 68382-655-05, 68382-655-10, 68382-655-30, 68382-655-77
Manufacturer
Zydus Pharmaceuticals (USA) Inc.
Effective date
2026-06-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
glyburide and metformin hydrochloride - Zydus Pharmaceuticals (USA) Inc.Zydus Pharmaceuticals (USA) Inc.2026-06-10HUMAN PRESCRIPTION DRUG LABEL
glyburide and metformin hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2021-12-27HUMAN PRESCRIPTION DRUG LABEL
Glyburide and Metformin Hydrochloride Tablets, USP Rx onlyPreferred Pharmaceuticals Inc.2020-06-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-655-01glyburide and metformin hydrochloride100 in 1 BOTTLETABLET1006
68382-655-05glyburide and metformin hydrochloride500 in 1 BOTTLETABLET5006
68382-655-06glyburide and metformin hydrochloride30 in 1 BOTTLETABLET306
68382-655-10glyburide and metformin hydrochloride1000 in 1 BOTTLETABLET10006
68382-655-16glyburide and metformin hydrochloride90 in 1 BOTTLETABLET906
68382-655-30glyburide and metformin hydrochloride10 in 1 BLISTER PACKTABLET106
68382-655-77glyburide and metformin hydrochloride10 in 1 CARTONTABLET106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-655GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5Current NDC, Legacy NDC, 7 package rows20221117_2239742b-74e1-4bc2-b5a8-15c4758d6f7b.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 3 of 157 · 3,125 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.ba0379cb-824e-4798-9ff9-99bcd1bea5cb2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackfb296500-55cb-45ce-be0c-59aa2e3d46242026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Pepcid Complete Dual Action Berry FlavorFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEJones Healthcare Group - Packaging Services, Incfff07b68-02ca-438e-8d53-5b4edf5eefc52026-08-25WarningsExact identifier
unii: H0G9379FGK
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-08-25WarningsExact identifier
unii: H0G9379FGK
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
SynjardyEMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.0fdd0255-0055-65f3-b2c0-db8fbb87beae2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
alogliptin and metformin hydrochlorideALOGLIPTIN AND METFORMIN HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltd14d98490-4f8f-4d2f-a4e9-7a3d7a0199ba2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Trijardy XREMPAGLIFLOZIN, LINAGLIPTIN, METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.71873567-9594-452a-bb92-34a129adecac2026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Hylands Naturals Earache DropsBELLADONNA LEAF,CALCIUM CARBONATE,CHAMOMILE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PATENS WHOLE,SULFURHyland's Inc.017ed754-9fe8-2cb5-e063-6294a90ab2f62026-08-24WarningsExact identifier
unii: H0G9379FGK
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
INVOKAMETCANAGLIFLOZIN AND METFORMIN HYDROCHLORIDEJanssen Pharmaceuticals, Inc.6868666b-c25e-40d1-9d1f-306bbe9390c12026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Genexa Antacid Maximum StrengthCALCIUM CARBONATEGenexa Inc.3a39d91c-2dcd-71d6-e063-6394a90a54742026-08-22WarningsExact identifier
unii: H0G9379FGK
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEScieGen Pharmaceuticals Inc4e4c4ba9-65c6-4273-8f6b-2423ab521dad2026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.073cf6d9-7142-4d8b-898e-174c62a1f76f2026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Actoplus MetPIOGLITAZONE AND METFORMIN HYDROCHLORIDETakeda Pharmaceuticals America, Inc.42e49120-6f3f-11db-9fe1-0800200c9a662026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Saxagliptin and MetforminSAXAGLIPTIN AND METFORMINMylan Pharmaceuticals Inc.cbf8677c-cafe-48bc-8844-0cc6547886bd2026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEQPharma,Inc.5866ca12-a28f-cbe7-e063-6294a90acc692026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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