FDA.reportPublic FDA data

NDC 16729-003-17 - Glimepiride

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
16729-003
Requested NDC
16729-003-17
Package NDCs from labels
16729-003-01, 16729-003-16, 16729-003-17
Manufacturer
Bryant Ranch Prepack
Effective date
2026-05-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glimepiride - Bryant Ranch PrepackBryant Ranch Prepack2026-05-19HUMAN PRESCRIPTION DRUG LABEL
Glimepiride - PD-Rx Pharmaceuticals, Inc.PD-Rx Pharmaceuticals, Inc.2026-01-07HUMAN PRESCRIPTION DRUG LABEL
Glimepiride - Northwind Health Company, LLCNorthwind Health Company, LLC2026-01-01HUMAN PRESCRIPTION DRUG LABEL
Glimepiride - Accord Healthcare Inc | Intas Pharmaceuticals LimitedAccord Healthcare Inc | Intas Pharmaceuticals Limited2025-10-17HUMAN PRESCRIPTION DRUG LABEL
Glimepiride - REMEDYREPACK INC.REMEDYREPACK INC.2025-03-25HUMAN PRESCRIPTION DRUG LABEL
Glimepiride - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2024-05-10HUMAN PRESCRIPTION DRUG LABEL
Glimepiride - A-S Medication SolutionsA-S Medication Solutions2023-02-28HUMAN PRESCRIPTION DRUG LABEL
GLIMEPIRIDE - DIRECT RXDIRECT RX2023-01-11HUMAN PRESCRIPTION DRUG LABEL
Glimepiride - St. Mary’s Medical Park PharmacySt. Mary’s Medical Park Pharmacy2022-12-22HUMAN PRESCRIPTION DRUG LABEL
Glimepiride - REMEDYREPACK INC.REMEDYREPACK INC.2022-06-09HUMAN PRESCRIPTION DRUG LABEL
Glimepiride - Proficient Rx LPProficient Rx LP2022-04-01HUMAN PRESCRIPTION DRUG LABEL
Glimepiride - RedPharm Drug, Inc.RedPharm Drug, Inc.2022-01-20HUMAN PRESCRIPTION DRUG LABEL
Glimepiride - Quality Care Products, LLCQuality Care Products, LLC2021-04-14HUMAN PRESCRIPTION DRUG LABEL
Glimepiride - NuCare Pharmaceuticals, Inc.NuCare Pharmaceuticals, Inc.2021-02-23HUMAN PRESCRIPTION DRUG LABEL
Glimepiride - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2021-02-18HUMAN PRESCRIPTION DRUG LABEL
Glimepiride - Denton Pharma, Inc. DBA Northwind PharmaceuticalsDenton Pharma, Inc. DBA Northwind Pharmaceuticals2020-12-30HUMAN PRESCRIPTION DRUG LABEL
Glimepiride - Denton Pharma, Inc. dba Northwind PharmaceuticalsDenton Pharma, Inc. dba Northwind Pharmaceuticals2020-09-15HUMAN PRESCRIPTION DRUG LABEL
Glimepiride - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2018-06-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-003-01Glimepiride100 in 1 BOTTLETABLET10010
16729-003-16Glimepiride500 in 1 BOTTLETABLET50010
16729-003-17Glimepiride1000 in 1 BOTTLETABLET100010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-003GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]9Current NDC, Legacy NDC, 3 package rows20231129_9b74fbac-9e04-4927-9981-1e3dace89c6d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-003-01EA - Each16729-0030076d1ca-2a13-4bfb-98ee-17258bd8f77a12013-02-13
16729-003-16EA - Each16729-003f401dc9e-e474-41a4-b426-cd34551a4dc812016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]5
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]5
POVIDONEINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]5
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]4
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]4
glimepirideACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [PROFICIENT RX LP]1
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [NORTHWIND PHARMACEUTICALS]1
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [NORTHWIND PHARMACEUTICALS]1
glimepirideACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [PROFICIENT RX LP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGLIMEPIRIDE TABLET [PROFICIENT RX LP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [PROFICIENT RX LP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [PROFICIENT RX LP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [PROFICIENT RX LP]1
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [PROFICIENT RX LP]1

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 8 of 11 · 206 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlimepirideGLIMEPIRIDEBryant Ranch Prepack661b5b13-6334-4965-8dc5-709e190805842025-01-28Warnings, Adverse reactionsExact identifier
rxcui: 199245
unii: 6KY687524K
GlimepirideGLIMEPIRIDEDirect_Rxfd26934e-daea-f47b-e053-6394a90a4bc62025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 199246
unii: 6KY687524K
Prunus IronPRUNUS IRONUriel Pharmacy Inc.091be588-b62e-4919-8e9e-3edb9792d3192025-01-22WarningsExact identifier
unii: 1K09F3G675
9533ad41-0cf3-49a3-9f17-d87337b1d2872cf5e49d-5058-47d3-844b-4dbd40ddc2932025-01-09Warnings, Adverse reactionsExact identifier
spl set id: 2cf5e49d-5058-47d3-844b-4dbd40ddc293
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.11ae3189-6139-4470-95d5-72abc0f5b0d02025-01-08Warnings, Adverse reactionsExact identifier
rxcui: 199246
unii: 6KY687524K
Ferrum Silicicum UrticaFERRUM SILICICUM URTICAUriel Pharmacy Inc.09829ac4-c074-7315-e063-6394a90adf592025-01-07WarningsExact identifier
unii: 1K09F3G675
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.2794f86b-d521-414b-8154-5dd1e25196532025-01-03Warnings, Adverse reactionsExact identifier
rxcui: 199246
unii: 6KY687524K
GlimepirideGLIMEPIRIDEGolden State Medical Supply, Inc.4f83e203-c102-47fa-bb8e-4fc5541e0d6f2024-12-05Warnings, Adverse reactionsExact identifier
rxcui: 199247
rxcui: 199245
rxcui: 199246
unii: 6KY687524K
GlimepirideGLIMEPIRIDEAmerican Health Packaging0003458f-352a-46fa-9d99-230daa76ae292024-11-13Warnings, Adverse reactionsExact identifier
rxcui: 199247
rxcui: 199245
rxcui: 199246
unii: 6KY687524K
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
unii: FZ989GH94E
GlimepirideGLIMEPIRIDEA-S Medication Solutions0c25c987-856f-448d-903a-e2c94049b0a72024-10-25Warnings, Adverse reactionsExact identifier
rxcui: 199247
unii: 6KY687524K
GlimepirideGLIMEPIRIDEA-S Medication Solutions79ee7533-f75d-4c49-b396-b339654f5c442024-10-25Warnings, Adverse reactionsExact identifier
rxcui: 199247
unii: 6KY687524K
CaladrylFERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDEBausch Health US, LLC67d4fd42-9fed-4238-9f5a-c9403abbcf202024-10-17WarningsExact identifier
unii: 1K09F3G675
GlimepirideGLIMEPIRIDEFlorida Pharmaceutical Products, LLC8ff0de99-272e-4e68-9caf-69f3f146ac292024-10-08Warnings, Adverse reactionsExact identifier
rxcui: 199247
rxcui: 199245
rxcui: 199246
unii: 6KY687524K
GlimepirideGLIMEPIRIDECarlsbad Technology, Inc.72d88c6d-2f0a-4bf8-aa7f-1e18117941872024-10-02Warnings, Adverse reactionsExact identifier
rxcui: 199247
rxcui: 199245
rxcui: 199246
unii: 6KY687524K
GlimepirideGLIMEPIRIDEDirect_rx230949fd-563e-8dbf-e063-6394a90ab9b62024-09-26Warnings, Adverse reactionsExact identifier
rxcui: 199247
unii: 6KY687524K
GlimepirideGLIMEPIRIDEA-S Medication Solutions1e5d562e-b3bf-4502-adc8-c89c8818a9bc2024-09-18Warnings, Adverse reactionsExact identifier
rxcui: 199246
unii: 6KY687524K
GlimepirideGLIMEPIRIDEA-S Medication Solutions01196f54-32c8-41a0-b0ed-7968ca5d2fa22024-09-18Warnings, Adverse reactionsExact identifier
rxcui: 199246
unii: 6KY687524K
CalamineCALAMINE AND ZINC OXIDEStrategic Sourcing Services, LLC22173332-9d09-768c-e063-6394a90a94e12024-09-14WarningsExact identifier
unii: 1K09F3G675
GlimepirideGLIMEPIRIDEProficient Rx LP1f102e4c-1954-4f17-8c60-4dad79f25a252024-09-01Warnings, Adverse reactionsExact identifier
rxcui: 199245
unii: 6KY687524K

Reported adverse events (FAERS/openFDA)#

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