NDC 68788-8341-01 - 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
68788-8341
Requested NDC
68788-8341-01
Package NDCs from labels
68788-8341-3, 68788-8341-6, 68788-8341-9, 68788-8341-1, 68788-8341-8, 68788-8341-01
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-05-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glyburide and Metformin Hydrochloride - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2026-05-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8341-1Glyburide and Metformin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1004
68788-8341-3Glyburide and Metformin Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
68788-8341-6Glyburide and Metformin Hydrochloride60 in 1 BOTTLETABLET, FILM COATED604
68788-8341-8Glyburide and Metformin Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1204
68788-8341-9Glyburide and Metformin Hydrochloride90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8341GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 5 package rows20240517_c284c146-436b-4eea-9dca-d7d21c82778c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8341-1EA - Each68788-83416df5284e-ca0b-418a-93ca-5a1d140e7feb12023-03-13
68788-8341-3EA - Each68788-83411eb74ae8-616b-4c73-b7ac-c3198a4ed2ef12023-03-13
68788-8341-6EA - Each68788-8341dc3f0ebf-7a64-44ad-8507-ad3e7071434412023-03-13
68788-8341-8EA - Each68788-8341817cc0b7-b217-4cd2-83be-c1dd7440e9dd12023-03-13
68788-8341-9EA - Each68788-834113c692d5-7334-4840-a09f-1dd8d96a313812023-03-13

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 4 of 124 · 2,478 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.4d087f00-580b-4b9d-80d9-f97930153e722026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.5d8d654a-9bb4-4c87-ab43-c21c4e8747082026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Metformin HClMETFORMIN HCLPD-Rx Pharmaceuticals, Inc.c8e50300-1838-4c51-8d9d-ebbaaf0f39912026-08-03Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1d0b74de-ef4c-4dd2-8019-2ddb409c60b42026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.59a4ccda-5487-4ac4-9373-0c0fc8b7c88b2026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f55a245b-a786-4a4a-b11c-c61d48294b012026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.41408f64-d366-403e-9595-464ab25c6f972026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.68d0b1a6-c99e-42cf-afdf-b71ee73c44242026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.9171d369-d35a-40e4-a9ad-26484e66fc5e2026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.30658e19-8e6e-49aa-a007-e414224797c52026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.1503bbe4-0ac5-479b-9900-d38e49236bf02026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECardinal Health 107, LLC46cb7e3f-c739-433d-9dbe-427c2d95bef12026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H

Reported adverse events (FAERS/openFDA)#

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