NDC 20091-533 - 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
20091-533
Package NDCs from labels
20091-533-01, 20091-533-05, 20091-533-10
Manufacturer
Provident Pharmaceutical, Inc
Effective date
2007-04-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metformin Hydrochloride - Provident Pharmaceutical, IncProvident Pharmaceutical, Inc2007-04-05HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
20091-533-01Metformin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001
20091-533-05Metformin Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5001
20091-533-10Metformin Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
20091-533METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PROVIDENT PHARMACEUTICAL, INC]13 package rows20070517_99EB1A81-8472-4CFB-BAD8-739636AB5BEC.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
20091-533-01EA - Each20091-5333bb73f82-11aa-417e-a2c1-e8e16a2296e612013-02-13
20091-533-05EA - Each20091-5336f4ea3de-30f4-420f-a2a5-6cd8c5c9650112013-02-13
20091-533-10EA - Each20091-5334f1a2e6e-77ba-40a5-96de-3a44484d50e812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
metformin hydrochlorideACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PROVIDENT PHARMACEUTICAL, INC]1
metforminACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PROVIDENT PHARMACEUTICAL, INC]1
carnauba waxINACTIVE INGREDIENTMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PROVIDENT PHARMACEUTICAL, INC]1
crospovidoneINACTIVE INGREDIENTMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PROVIDENT PHARMACEUTICAL, INC]1
hypromelloseINACTIVE INGREDIENTMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PROVIDENT PHARMACEUTICAL, INC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PROVIDENT PHARMACEUTICAL, INC]1
polydextroseINACTIVE INGREDIENTMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PROVIDENT PHARMACEUTICAL, INC]1
polyethylene glycolINACTIVE INGREDIENTMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PROVIDENT PHARMACEUTICAL, INC]1
povidoneINACTIVE INGREDIENTMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PROVIDENT PHARMACEUTICAL, INC]1
pregelatinized starchINACTIVE INGREDIENTMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PROVIDENT PHARMACEUTICAL, INC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PROVIDENT PHARMACEUTICAL, INC]1
triacetinINACTIVE INGREDIENTXHX3C3X673METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PROVIDENT PHARMACEUTICAL, 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 5 of 9 · 166 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.403349a1-ec19-8982-e063-6294a90aa0602025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECoupler LLC3eeee3b7-188a-05a0-e063-6294a90a18532025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAscend Laboratories, LLC8c7835fa-3f68-4850-b1da-34893bafb4852025-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3d450933-8d9d-27de-e063-6294a90ae6d92025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3cbb802d-d493-255e-e063-6294a90a32f22025-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.e1ebb146-acfd-4301-a79c-f5bb243f85752025-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HCLMETFORMIN HCLDirect_Rx2ffeb25a-76a9-01e6-e063-6394a90ae3322025-07-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
Metformin HCLMETFORMIN HCLDirect_Rx3ac4e864-4b8a-13b1-e063-6294a90ada662025-07-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3ab4efb6-bd30-2583-e063-6294a90a415b2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions72dbc087-9a84-4126-bf54-c5254a8b129c2025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3982b985-9184-0e17-e063-6394a90aae052025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsbb62088f-e9af-4644-9f57-cb90bab0f1992025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions59743092-bae1-4725-ac4b-c8a8b0a81c1e2025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3890b116-7c3c-e48e-e063-6294a90a0c8a2025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC390c3bdf-bfaf-203e-e063-6394a90a7d202025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutionsec3a9070-3745-41fb-b610-8d06129d8fd92025-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions51e1fe6e-a7fa-47a5-bbd5-73b275230c7f2025-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsf6581ce6-0f9f-4887-ae83-4c6ecde619f32025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.33155746-c2ef-12f4-e063-6294a90a039c2025-04-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECoupler, LLC32ff33ed-89ed-c391-e063-6294a90ae4142025-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004

Reported adverse events (FAERS/openFDA)#

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