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 11 of 157 · 3,125 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675
Metformin HydrochlorideMETFORMIN HYDROCHLORIDE TABLETGranules India Ltd8cd5555c-f6b2-28d8-e053-2a95a90a5f1e2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
Glipizide and Metformin HydrochlorideGLIPIZIDE AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals USA Inc.1b18b903-eb52-4d08-b4a5-f984957eb1162026-06-27Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEUnit Dose Solutions, Inc.552ad61d-bafd-478d-e063-6294a90a02f92026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLUnit Dose Solutions, Inc.552df462-6dcb-e6f2-e063-6294a90aacfe2026-06-26Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Vanilla Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f6d2c-9b8c-aa52-e063-6294a90a787e2026-06-26WarningsExact identifier
unii: 15FIX9V2JP
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEMarlex Pharmaceuticals, Inc.3d6f397b-e909-bee9-e063-6294a90aba172026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Glipizide and Metformin HClGLIPIZIDE AND METFORMIN HCLHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.94a7f96e-2ed1-432d-bc6a-5840863816e12026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEViona Pharmaceuticals Inc85027e6c-d35b-49eb-a234-dd71aa77aee02026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETSAiPing Pharmaceutical, Inc.96c8a89d-99db-24b1-e053-2a95a90ac2b82026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.41a8bb80-7b0b-476c-8134-5d161c3239c82026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551ab7d1-dd2f-c6d8-e063-6394a90aff652026-06-25WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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