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 14 of 157 · 3,125 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
it cosmetics Your Skin But Better CC Plus Natural Matte Color Correcting Pore Refining Full Coverage Skin Balancing Serum Broad Spectrum SPF 40 SunscreenENSULIZOLE, OCTISALATE AND TITANIUM DIOXIDEIT COSMETICS, LLCf2990320-b61d-40b8-ba79-18d6b37e7f522026-06-11WarningsExact identifier
unii: 15FIX9V2JP
Dapagliflozin and Metformin HydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEGolden State Medical Supply, Inc.54027b70-53e7-3710-e063-6394a90aa04c2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepack4d245bc3-0add-4651-b441-86b93c5ac6812026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Glipizide and Metformin HydrochlorideGLIPIZIDE AND METFORMIN HYDROCHLORIDETeva Pharmaceuticals USA, Inc.03d9ce02-0559-494c-a53d-de9b9a64b6062026-06-11Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
glyburide and metformin hydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.2239742b-74e1-4bc2-b5a8-15c4758d6f7b2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206748
ndc (package): 68382-655-30
ndc (package): 68382-653-10
ndc (package): 68382-655-10
ndc (package): 68382-655-05
ndc (package): 68382-654-30
ndc (package): 68382-653-16
ndc (package): 68382-653-01
ndc (package): 68382-655-01
ndc (package): 68382-653-05
ndc (package): 68382-655-06
ndc (package): 68382-654-16
ndc (package): 68382-654-77
ndc (package): 68382-653-30
ndc (package): 68382-654-06
ndc (package): 68382-654-05
ndc (package): 68382-654-10
ndc (package): 68382-655-77
ndc (package): 68382-655-16
ndc (package): 68382-654-01
ndc (package): 68382-653-77
ndc (package): 68382-653-06
ndc (product): 68382-653
ndc (product): 68382-655
ndc (product): 68382-654
ndc11 (package): 68382065530
rxcui: 861748
rxcui: 861753
rxcui: 861743
spl id: 10f3fa5d-7b0b-445b-8a83-7071295687af
spl set id: 2239742b-74e1-4bc2-b5a8-15c4758d6f7b
unii: 786Z46389E
unii: SX6K58TVWC
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECoupler LLC53e950f5-c58f-78e3-e063-6294a90a53e92026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
GUNA-AWARENESSBETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE - SUS SCROFA FRONTAL LOBE - SUS SCROFA TEMPORAL LOBE - THYROTROPIN ALFA - UBIDECARENONE - VANADIUM - ZINC - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN -Guna spa10e46b39-7903-4390-b72d-865291245b4c2026-06-10WarningsExact identifier
unii: H0G9379FGK
Metformin HydrochlorideMETFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETSQingdao BAHEAL Pharmaceutical Co. Ltd.7ea6e623-4073-4671-e053-2a91aa0a3ca32026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
glyburide and metformin hydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limiteddf752bd4-e197-40a4-a01b-d48ba2c105162026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206748
rxcui: 861748
rxcui: 861753
rxcui: 861743
unii: 786Z46389E
unii: SX6K58TVWC
Childrens AntacidCALCIUM CARBONATERite Aid Corporationd09c2d99-9a1f-4eae-a048-ab6dbf74a7982026-06-09WarningsExact identifier
unii: H0G9379FGK
Maximum Strength Calcium Carbonate 1000mgCALCIUM CARBONATE CHEWABLE TABLETSCVS HEALTH CORP24ce4597-b571-3cbf-e063-6394a90a8ea22026-06-09WarningsExact identifier
unii: H0G9379FGK
Tums Chewy Bites with Gas ReliefCALCIUM CARBONATE AND SIMETHICONEHaleon US Holdings LLC6d7be7e4-4bff-4cfd-bbbe-df412ac9db102026-06-09WarningsExact identifier
unii: H0G9379FGK
RE-NUTRIV AGE REVERSAL VITAL RADIANCE SERUM FOUNDATION SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d76b02-442e-7a5d-e063-6394a90ae1b32026-06-09WarningsExact identifier
unii: 15FIX9V2JP
FUTURIST HYDRATING COLLAGEN-PEPTIDE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d9d689-4a86-5b9c-e063-6394a90aef182026-06-09WarningsExact identifier
unii: 15FIX9V2JP
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMARKSANS PHARMA LIMITEDb8004451-7b26-425b-b5ea-cbb1b08e30e32026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEQPharma Inc5269e91f-7e93-9405-e063-6294a90a32172026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEQPharma Inc53bde438-4277-f418-e063-6394a90a5ea22026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Eryfotona Ageless Tinted Lightweight Emulsion SunscreenTITANIUM DIOXIDEISDIN Corp.293a1116-e8a2-495f-83db-20dd82ed13c22026-06-08WarningsExact identifier
unii: 15FIX9V2JP
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMylan Pharmaceuticals Inc.4f70f907-08d5-4c2e-a4be-32c6124faa7b2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Eryfotona Actinica TintedTITANIUM DIOXIDEISDIN Corp.97357703-0e93-4216-bd1b-a9b2027819592026-06-05WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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