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 84 of 153 · 3,056 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAscend Laboratories, LLC8c7835fa-3f68-4850-b1da-34893bafb4852025-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
CareOne Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEAmerican Sales Company19045840-2d25-43af-8c92-f36c8b903b282025-08-28WarningsExact identifier
unii: H0G9379FGK
Ki No SinCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.21fa2bad-5b8b-8aac-e063-6394a90a9f492025-08-27WarningsExact identifier
unii: H0G9379FGK
R CosCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.21fa767a-1344-5ed9-e063-6394a90a5fe62025-08-27WarningsExact identifier
unii: H0G9379FGK
Na Mi CalCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.20cfbcd1-eb13-933c-e063-6294a90a7e592025-08-27WarningsExact identifier
unii: H0G9379FGK
Ki No SinCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.20cf8f80-c638-4d94-e063-6294a90a54002025-08-27WarningsExact identifier
unii: H0G9379FGK
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3d55291c-9d4c-85c3-e063-6394a90af3302025-08-27WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3d565612-ade5-bfb3-e063-6294a90a0c652025-08-27WarningsExact identifier
unii: 15FIX9V2JP
Sun Bum 30 Mineral Tinted Sunscreen FaceTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3a290aad-7f40-cb10-e063-6394a90a2e692025-08-27WarningsExact identifier
unii: 15FIX9V2JP
ACID REDUCER COMPLETEFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDESafeway484ad323-82cf-4157-bacb-236af8210c872025-08-27WarningsExact identifier
unii: H0G9379FGK
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3d450933-8d9d-27de-e063-6294a90ae6d92025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MGC Health Calcium Carbonate Antacid Assorted FruitsCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3d4617bb-dfa8-ab8f-e063-6394a90a641b2025-08-26WarningsExact identifier
unii: H0G9379FGK
MGC Health Calcium Carbonate Antacid Assorted BerriesCALCIUM CARBONATEMedical Group Care LLC3d465ecd-12cc-ffbd-e063-6394a90aabac2025-08-26WarningsExact identifier
unii: H0G9379FGK
MGC Health Calcium Carbonate Antacid Assorted FruitsCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3d46afba-ff44-0088-e063-6294a90a919e2025-08-26WarningsExact identifier
unii: H0G9379FGK
Exchange Select Calcium Carbonate Antacid Smoothies Extra Strength Assorted BerriesCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3d470e3a-3c3f-d2b8-e063-6394a90a7edb2025-08-26WarningsExact identifier
unii: H0G9379FGK
MGC Health Calcium Carbonate Antacid Assorted BerriesCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.f24634a6-bb7e-42e3-a775-723ac030eb1a2025-08-26WarningsExact identifier
unii: H0G9379FGK
MGC Health Calcium Carbonate Antacid Tropical FruitCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.10d8c5b6-8541-4c82-aa6d-9ae8c624e45e2025-08-26WarningsExact identifier
unii: H0G9379FGK
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepackf2318509-9a49-4c99-a08b-22381f17aacd2025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3d0359b6-088f-aa54-e063-6394a90a422f2025-08-23WarningsExact identifier
unii: 15FIX9V2JP
Leader Ultra Strength AntacidCALCIUM CARBONATECARDINAL HEALTH 110, LLC. DBA LEADEReab5a905-67fb-494e-8f55-aeeab4c2dce22025-08-22WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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