FDA.reportPublic FDA data

NDC 82922-100 - SITAGLIPTIN - METFORMIN

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
82922-100
Package NDCs from labels
82922-100-01
Manufacturer
Truemed Group LLC
Effective date
2023-04-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SITAGLIPTIN - METFORMIN - Truemed Group LLCTruemed Group LLC2023-04-14HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82922-100-012024-07-30C16284748780-11030e365-4cb4-111a-e063-dadaa90a10e2SITAGLIPTIN - METFORMIN
82922-100-012024-01-30C16284748780-11030e365-4cb4-111a-e063-dadaa90a10e2SITAGLIPTIN - METFORMIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82922-100-01SITAGLIPTIN - METFORMIN28 in 1 BOTTLE, PLASTICTABLET281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82922-100SITAGLIPTIN - METFORMIN TABLET [TRUEMED GROUP LLC]11 package rows20230416_f9519812-a5b0-1a19-e053-6294a90a471d.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 1 of 1 ยท 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sitagliptin and metformin hydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.4d812277-21a8-4de3-b728-e3fdd01305b52026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QFP0P1DV7Z
Sitagliptin and metformin hydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limitede07abcb1-1f0c-4cad-8405-8eedba4b8ff82026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QFP0P1DV7Z
ZITUVIMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limited0098dec4-f0e5-45d5-8aa4-5d0faf9ab1422026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QFP0P1DV7Z
ZITUVIMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.eeda90a0-4941-4716-8684-f9f12cbdf3af2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QFP0P1DV7Z
ZITUVIMET XRSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limited4bade493-499e-434a-97a0-26ca689176232026-01-05Exact identifier
unii: QFP0P1DV7Z
ZITUVIMET XRSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals USA Inc.2f635b36-e86a-4e53-8eaf-589917b5f3422025-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QFP0P1DV7Z
ZITUVIOSITAGLIPTINZydus Pharmaceuticals (USA) Inc.abfdea45-c0ca-41e3-a510-e89810bc9cfe2025-01-31Warnings, Adverse reactionsExact identifier
unii: QFP0P1DV7Z
ZITUVIOSITAGLIPTINZydus Lifesciences Limitedb2da9d77-154b-48f7-8793-3f4a24dfafc62025-01-31Warnings, Adverse reactionsExact identifier
unii: QFP0P1DV7Z
SitagliptinSITAGLIPTINZydus Pharmaceuticals (USA) Inc.6a970e80-b753-48fa-9fff-87e7a50449822025-01-31Warnings, Adverse reactionsExact identifier
unii: QFP0P1DV7Z
SitagliptinSITAGLIPTINZydus Lifesciences Limitede5ac97e8-3a0b-4750-8e3f-3374125707462025-01-31Warnings, Adverse reactionsExact identifier
unii: QFP0P1DV7Z
BRYNOVINSITAGLIPTIN HYDROCHLORIDE ORALAzurity Pharmaceuticals, Inc.9468a2f3-3ebe-40bd-a3b4-d78d9eb47e042025-01-02Warnings, Adverse reactionsExact identifier
unii: QFP0P1DV7Z
Sitagliptin and Metformin HydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals USA Inc.d3a728a0-decb-4340-8ee4-c5e27c13eb192024-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QFP0P1DV7Z
Sitagliptin and Metformin HydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limiteda07fa1d9-7171-4f2a-ab34-f8fa410364a62024-08-24Exact identifier
unii: QFP0P1DV7Z
f9519812-a5b1-1a19-e053-6294a90a471df9519812-a5b0-1a19-e053-6294a90a471d2023-04-14Exact identifier
spl id: f9519812-a5b1-1a19-e053-6294a90a471d
spl set id: f9519812-a5b0-1a19-e053-6294a90a471d

Reported adverse events (FAERS/openFDA)#

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