FDA.reportPublic FDA data

NDC 0591-2713 - 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
0591-2713
Package NDCs from labels
0591-2713-01, 0591-2713-05, 0591-2713-10
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
0591-2713-01Metformin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001
0591-2713-05Metformin Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5001
0591-2713-10Metformin Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2713METFORMIN 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 4 of 9 · 166 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC273d86b0-9d30-48c9-8918-c5e1ececa9512026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.ca71c133-6c38-4b9e-80af-1949634157f42026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.e3e9b582-fd15-4fe0-a210-398d9149696e2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENorthwind Health Company, LLCf31c08fc-cda1-349c-e053-2a95a90aba152026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENorthwind Health Company, LLCdae7b1c1-7ff1-883c-e053-2a95a90a1a2b2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENorthwind Health Company, LLC0178b9dd-bafa-9e81-e063-6294a90a88b02026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENorthwind Health Company, LLCdb113f46-6fac-9005-e053-2995a90a017a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAscend Laboratories, LLC0ff1ba75-3c86-4baf-a6b1-1bb8838398662025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.b63bfafa-db4c-4fb8-84cd-ff73a5e7d3202025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
Metformin HClMETFORMIN HCLA-S Medication Solutionsc37b511c-1e33-4941-bd12-df0447a50ca92025-12-06Warnings, Adverse reactionsExact identifier
rxcui: 861010
Metformin HClMETFORMIN HCLQPharma, Inc.06ade2e1-5981-4e3d-b7e9-7ff083eb45512025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDE TABLETQuallent Pharmaceuticals Health LLCf39ee08d-73db-71b9-e053-2995a90a877c2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPrecision Dose, Inc.37ff1b8e-a434-41c0-82e1-4583842921a52025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
Metformin HClMETFORMIN HCLA-S Medication Solutionsd43ccbc3-eb0b-400e-a6fa-31202dec3a712025-11-10Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HClMETFORMIN HCLA-S Medication Solutions21cbb326-9dee-40ec-ac25-0dad79e3302b2025-11-07Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HClMETFORMIN HCLA-S Medication Solutions397c2bf4-35be-4e75-b5a6-426e3fa095482025-11-06Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HClMETFORMIN HCLPD-Rx Pharmaceuticals, Inc.235680e6-1c3e-45b8-902e-866583f1aef32025-11-04Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMullan Pharmaceutical Inc.082b4de9-e452-fe71-e063-6394a90ac8632025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.0230a3c3-34cf-478b-88c3-4d96e53000182025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.c72cfd1a-dce9-43a3-88e2-3cf1d9078b522025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004

Reported adverse events (FAERS/openFDA)#

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