FDA.reportPublic FDA data

NDC 0228-2657 - 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
0228-2657
Package NDCs from labels
0228-2657-11, 0228-2657-10, 0228-2657-50, 0228-2657-96
Manufacturer
Actavis Elizabeth LLC
Effective date
2007-03-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
metformin hydrochloride - Actavis Elizabeth LLCActavis Elizabeth LLC2007-03-28HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0228-2657-10metformin hydrochloride100 in 1 BOTTLETABLET1001
0228-2657-11metformin hydrochloride100 in 1 BOTTLETABLET1001
0228-2657-50metformin hydrochloride500 in 1 BOTTLETABLET5001
0228-2657-96metformin hydrochloride1000 in 1 BOTTLETABLET10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-2657METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET [ACTAVIS ELIZABETH LLC]14 package rows20070413_A3878E6A-ABB9-4994-8D5A-EA4DC2E85226.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
metformin hydrochlorideACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET [ACTAVIS ELIZABETH LLC]1
metforminACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET [ACTAVIS ELIZABETH LLC]1
crospovidoneINACTIVE INGREDIENTMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET [ACTAVIS ELIZABETH LLC]1
hydroxypropyl methylcelluloseINACTIVE INGREDIENTMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET [ACTAVIS ELIZABETH LLC]1
maltodextrinINACTIVE INGREDIENTMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET [ACTAVIS ELIZABETH LLC]1
polythylene glycolINACTIVE INGREDIENTMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET [ACTAVIS ELIZABETH LLC]1
povidoneINACTIVE INGREDIENTMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET [ACTAVIS ELIZABETH LLC]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APMETFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET [ACTAVIS ELIZABETH LLC]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 7 of 9 · 166 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepacked6e6f87-ddd7-4c9d-a263-47154d3a94782024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions011de1a5-1ac0-4831-9e8d-26ec79ba22052024-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack6a9ab61a-a5d0-41ef-b528-59eac6b4cfe62024-08-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack32d6c5f4-0116-4e38-b179-e1967ae63e662024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack4670d280-53c3-4c51-b3c5-26d71e47bddc2024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.041632fa-9bf4-8d7c-e063-6294a90adefb2024-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions1ef6c527-89f5-4830-8900-7532b0a7ef262024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions1c046303-993c-4111-ac9a-40a0d97ca6a22024-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions1a7f7ef3-a94b-4ff6-a9f2-f5de4a99c7f62024-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsafb183f6-a13c-4f00-82d5-9fe336173d342024-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsc2783b59-7b20-4d4c-a3ca-03ed60dcf2c32024-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions2be73d5e-7682-4ad3-831b-8c1ea73e38de2024-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP928ef685-80cb-42a9-a155-3c21c9b1dd672024-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861004
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.1182bf60-3578-a0ed-e063-6394a90aa50f2024-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack9c33414b-5dbb-4ce9-910b-9480d45e50ee2024-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepackf9e78e0f-6a0a-4db3-bc09-5500748f9c842024-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions3c607f04-d36f-4cf8-9cc9-7f2af08b40982024-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions7cc82387-8bb0-4bee-9967-cb13eab1d8012024-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCb090b18b-b53c-4c92-892f-d11551cfedc32023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsd0bc43a4-301f-4002-9b58-bd81dddf27902023-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010

Reported adverse events (FAERS/openFDA)#

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