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 86 of 153 · 3,056 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ERBORIAN CC CREME Color Correcting SPF 25 BRONZEOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L4aa12cf0-0c48-4b40-9c9a-bd50523cce8a2025-08-12WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN CC CREME Color Correcting SPF 25 MEDIUMOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L5bdaa149-47aa-40ac-b17a-ea6d290998622025-08-12WarningsExact identifier
unii: 15FIX9V2JP
MGC Health Calcium Carbonate Antacid Assorted BerriesCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.b84d80c6-0240-4276-8e47-74a918f3d86a2025-08-12WarningsExact identifier
unii: H0G9379FGK
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.15536331-fec5-4daa-824d-2e32d63e64522025-08-12WarningsExact identifier
unii: 15FIX9V2JP
EmbrivaASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDEOncora Pharma, LLC3c362de4-1ed9-83be-e063-6394a90a10fc2025-08-12WarningsExact identifier
unii: H0G9379FGK
UP AND UP DUAL ACTION ACID REDUCER ANTACIDFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDETarget Corporation8e925e57-9036-4658-bf07-578e22675af82025-08-11WarningsExact identifier
unii: H0G9379FGK
Dolce and Gabbana Everlast Foundation SPF 20 22N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lad8afa83-2844-422c-b2bf-b5a61be368b12025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 23W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L96973dee-681b-4c5d-b31f-de05cd79fa182025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 24N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lecda3658-eca1-48c2-9eff-e22fd1ff70df2025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 25W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc6f27df4-6de4-45e4-90cb-ea8b0d29dbd32025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 26W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L968abacd-8b99-4529-a627-2b56cdf99e1b2025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 27N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.La9068dc0-bc48-498b-adc9-57ff810384af2025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 28W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L37f01f66-c604-4fc3-a263-2089db91283f2025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 29W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lbca57893-bd2d-44ac-a503-2f11c3b62bf22025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 30N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L37188b77-ab0b-4bea-b839-99e589600a2b2025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 31N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc89e45d6-2322-4913-a557-e1780a86fd632025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Acid Reducer Plus AntacidFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDECVS Pharmacyd6f0b82c-3890-4e85-8b8a-354fb8d0b6402025-08-11WarningsExact identifier
unii: H0G9379FGK
Acid Reducer Plus AntacidFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDECVS Pharmacy509435e4-14fd-4e09-bdc1-ad295b46806b2025-08-11WarningsExact identifier
unii: H0G9379FGK
SUNSCREEN SPF50ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, TITANIUM DIOXIDEGuangzhou Tinsun Biotechnology Company Limited3bc1c6e9-1dd5-d7c6-e063-6394a90ad89e2025-08-07WarningsExact identifier
unii: 15FIX9V2JP
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.e1ebb146-acfd-4301-a79c-f5bb243f85752025-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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