FDA.reportPublic FDA data

NDC 50090-5396-01 - 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
50090-5396
Requested NDC
50090-5396-01
Package NDCs from labels
50090-5396-4, 50090-5396-2, 50090-5396-1, 50090-5396-3, 50090-5396-0, 50090-5396-01
Manufacturer
A-S Medication Solutions
Effective date
2023-03-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metformin Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2023-03-15Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5396-0Metformin Hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE6012
50090-5396-1Metformin Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE3012
50090-5396-2Metformin Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE9012
50090-5396-3Metformin Hydrochloride180 in 1 BOTTLETABLET, EXTENDED RELEASE18012
50090-5396-4Metformin Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE10012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5396METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 5 package rows20230317_a57e2890-d83b-488c-b221-2e8f8a78ed16.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5396-0EA - Each50090-5396dcdfd31e-f119-4e56-9ea7-260f9c9ff10e12022-07-06
50090-5396-1EA - Each50090-53966342a84a-1221-48b2-8250-102fa35156b212022-07-06
50090-5396-2EA - Each50090-539650e02479-b9bd-4a14-961b-6f28ce405da812022-01-06
50090-5396-3EA - Each50090-5396debbb3b5-5818-4f0e-b726-b3ebcb354dab12022-01-06
50090-5396-4EA - Each50090-5396492cc8c5-4613-4599-b657-94ff44650e0e12023-04-07

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 23 · 452 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dapagliflozin and metformin hydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEAscend Laboratories, LLCeadcc3ef-f5c2-4a56-a6aa-12909844144e2026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MetforminMETFORMIN ER 500 MGBryant Ranch Prepackc047cf64-467a-40f3-be46-a1926b3b8d562026-03-17Warnings, Adverse reactionsExact identifier
rxcui: 860975
unii: 786Z46389E
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMKC Pharmaceuticals, Inc.4d1d9b3a-ac5f-db27-e063-6294a90afc3f2026-03-16WarningsExact identifier
unii: K679OBS311
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRedicare LLC4d1e5089-22b0-7b3f-e063-6294a90a346a2026-03-16WarningsExact identifier
unii: K679OBS311
Metformin Hydrochloride Oral SolutionMETFORMIN HYDROCHLORIDEMICRO LABS LIMITEDfb90693a-074a-45be-94f4-ed6298b1f4e42026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HCLMETFORMIN HCLDirect_Rx498ac5fc-14be-d36a-e063-6394a90a30122026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.abd0dad9-5f29-4102-a099-dce7bdddb98b2026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
Metformin hydrochlorideMETFORMIN HYDROCHLORIDELegacy Pharmaceutical Packaging, LLCb51da8d7-ab4a-4c40-97c9-88bd379366d12026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
unii: 786Z46389E
MetforminMETFORMIN ER 500 MGLegacy Pharmaceutical Packaging, LLCd9e0816d-fd61-1ac2-e053-2995a90a40542026-03-11Warnings, Adverse reactionsExact identifier
rxcui: 860975
unii: 786Z46389E
Glipizide and Metformin HydrochlorideGLIPIZIDE AND METFORMIN HYDROCHLORIDEA-S Medication Solutions4a2d814b-93a1-4487-b789-dbafe9f0ffd32026-03-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Rain Renewal Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRain Eye Drops, LLCbb451b22-c4f6-291d-e053-2a95a90a78012026-03-06WarningsExact identifier
unii: K679OBS311
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEdirect rxc33e24e9-0441-6b94-e053-2a95a90a9c682026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
unii: 786Z46389E
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEA-S Medication Solutionsf43c087a-7135-4a79-8463-fe5e9319da912026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions75b25738-31e6-4b58-9d2b-f4a1ab4ab0902026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 860975
unii: 786Z46389E
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: K679OBS311
Discount Drug Mart Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMDiscount Drug Mart4ba1b369-54e2-5224-e063-6394a90a47692026-02-25WarningsExact identifier
unii: K679OBS311
Metformin Hydrochloride Oral SolutionMETFORMIN HYDROCHLORIDEBionpharma Inc.,3ab005d4-bc99-4fdb-e063-6394a90a51242026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMKC Pharmaceuticals, Inc.4bafa882-50b7-e3e2-e063-6294a90a76e32026-02-25WarningsExact identifier
unii: K679OBS311
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMethod Pharmaceuticals, LLC.4aa880a4-7ec0-9155-e063-6394a90a8f3e2026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEA-S Medication Solutionsd87dade1-55fe-4e77-91b9-b642022a2b8a2026-02-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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