NDC 20091-533-01 - 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
Requested NDC
20091-533-01
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
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

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 2 of 9 · 166 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEZydus Pharmaceuticals USA Inc.c82a10fa-1e8e-46b6-890a-737de3f34ee12026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.5aa1c86c-f2c8-49b1-8f81-47b11386c5d32026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAurobindo Pharma Limited4ac6d01a-af26-44e7-ae2e-3618de0080aa2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
Metformin HClMETFORMIN HCLPD-Rx Pharmaceuticals, Inc.fb890205-5d43-41eb-97b2-fb0dcdd3a9502026-07-13Warnings, Adverse reactionsExact identifier
rxcui: 861007
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAdvanced Rx of Tennessee, LLC5647230e-5bc6-1802-e063-6394a90a27242026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAurobindo Pharma Limitedfc466c46-abaa-4675-aef2-4b1a1adfd9122026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDE TABLETGranules India Ltd8cd5555c-f6b2-28d8-e053-2a95a90a5f1e2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEUnit Dose Solutions, Inc.552ad61d-bafd-478d-e063-6294a90a02f92026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HClMETFORMIN HCLUnit Dose Solutions, Inc.552df462-6dcb-e6f2-e063-6294a90aacfe2026-06-26Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMajor Pharmaceuticals5e783025-bf6d-465e-bf58-bcd253afad2c2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.4182bcf0-1f9a-4f3a-9428-86b5d757954f2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.62ca8af4-ff91-4bf6-b7c6-895b3b5ce8c32026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.14450912-54b5-4fc3-ba65-77ece864b2e72026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.902d1bc4-3f1f-4a1a-86d7-cf98c56a36842026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.33550b88-d4bb-4ce6-a7db-07c966f6984f2026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsf4fc759a-057e-4b5d-b8ab-13bc5eeb24e42026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions400ff9dc-9789-44ac-afb5-730b632a16672026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECoupler LLC53e950f5-c58f-78e3-e063-6294a90a53e92026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMARKSANS PHARMA LIMITEDb8004451-7b26-425b-b5ea-cbb1b08e30e32026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEQPharma Inc53bde438-4277-f418-e063-6394a90a5ea22026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004

Reported adverse events (FAERS/openFDA)#

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