FDA.reportPublic FDA data

NDC 0591-2775 - 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
0591-2775
Package NDCs from labels
0591-2775-60, 0591-2775-01, 0591-2775-25
Manufacturer
Watson Laboratories, Inc.
Effective date
2006-04-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metformin Hydrochloride Tablets Rx onlyWatson Laboratories, Inc.2006-04-05HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-2775-01Metformin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001
0591-2775-25Metformin Hydrochloride250 in 1 BOTTLETABLET, FILM COATED2501
0591-2775-60Metformin Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2775METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]13 package rows20060828_A757F9F8-A925-4E47-9B83-131CCCF8E470.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Metformin HydrochlorideACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]1
MetforminACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]1
hypromelloseINACTIVE INGREDIENTMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]1
lactose monohydrateINACTIVE INGREDIENTMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]1
microcrystalline celluloseINACTIVE INGREDIENTMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]1
povidoneINACTIVE INGREDIENTMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]1
red iron oxideINACTIVE INGREDIENTMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]1
tricetinINACTIVE INGREDIENTMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]1
vanillinINACTIVE INGREDIENTMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]1
yellow iron oxideINACTIVE INGREDIENTMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]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 9 · 166 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsa4679179-af2d-4c84-a1c8-ab0870a4585d2023-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
Metformin HClMETFORMIN HCLA-S Medication Solutions74f18a3e-0f5c-4172-b499-14f229b431c42023-09-10Warnings, Adverse reactionsExact identifier
rxcui: 861007
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP1b9b6db9-1bac-4252-a03c-18dc0271f05f2023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861004
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack88af3365-1145-45a1-ab0f-1c794f0c13db2023-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
Metformin HClMETFORMIN HCLBryant Ranch Prepack4bdd2faa-2125-4139-b958-196393e31b7e2023-05-24Warnings, Adverse reactionsExact identifier
rxcui: 861007
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack8ce6b615-2abd-4a5b-997b-11aa1aec142d2023-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HClMETFORMIN HCLA-S Medication Solutions4e345b8c-57ab-4f09-9cbe-1d255e9354ba2023-03-21Warnings, Adverse reactionsExact identifier
rxcui: 861007
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEGolden State Medical Supply, Inc.f86bda10-8b25-4125-8bb1-1b5917969ff02023-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack76879512-3ab4-4acf-92e6-bba0fb75dd0e2023-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepacka59327bd-a3ba-417b-9e91-4cd3a941e6402023-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepacka79d2674-071f-4641-9b11-406e02c5530a2023-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin hydrochlorideMETFORMIN HYDROCHLORIDEMacleods Pharmaceuticals Limited623b3bc6-1b07-4a04-bc7a-7fc695adf0632023-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC34aa1761-d16f-4bfc-b7fa-bf1b0387e8a32022-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd0bee456-c8cd-46a1-acb3-5313a8cddd302022-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HClMETFORMIN HCLProficient Rx LP53361a39-cb69-483b-a4be-3a4753bf1ba62022-06-01Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LPd51f3618-4166-4925-8994-968a653ebc462022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP5f243894-bda3-4fa9-97e4-209dcb389dee2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP738402d6-3700-46b2-a90c-2e8f2c354a392022-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
Metformin HClMETFORMIN HCLBryant Ranch Prepack1f8833f9-1232-4aa7-a0d4-04a9f87dc2f02021-11-01Warnings, Adverse reactionsExact identifier
rxcui: 861010
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack9632456f-57c2-444b-9f43-d9ca862681fe2021-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010

Reported adverse events (FAERS/openFDA)#

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