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 9 of 23 · 452 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions239834b0-121a-4903-b3ee-90bb4db4753b2026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions5f2023d2-05ae-489d-9e18-fb75057496bc2026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions1d7556eb-82b4-4085-b0b1-dc061b216feb2026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEQuallent Pharmaceuticals Health LLC6864ff5a-7512-4a4f-ad26-b2b9c58434142026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206145
rxcui: 860975
rxcui: 860981
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions8c248958-6c01-455e-89f5-959facb272ed2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions192970d3-826a-4b69-a525-9742794dc19c2026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
unii: 786Z46389E
Carboxymethylcellulose Sodium Eye Drops 0.5%CARBOXYMETHYLCELLULOSE SODIUM EYE DROPS 0.5%Aurolabe8b4df3b-3d81-b3ca-e053-2a95a90af2ec2026-01-27WarningsExact identifier
unii: K679OBS311
AURO-CMCCARBOXYMETHYLCELLULOSE EYE DROPS 0.5%Aurolabe90b397f-fe64-8674-e053-2995a90a223f2026-01-27WarningsExact identifier
unii: K679OBS311
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Incdfac4d9c-2f20-417c-a1be-4f1c2738f3512026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
unii: 786Z46389E
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.a0ff8ee6-0da8-40f8-b5b0-a7b334e1a15f2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC273d86b0-9d30-48c9-8918-c5e1ececa9512026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.64650d2c-2bec-4470-b250-29d01caa1ebe2026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206145
rxcui: 860981
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.ca71c133-6c38-4b9e-80af-1949634157f42026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
unii: 786Z46389E
Family Care Single Use Lubricant Eye Drop 0.4mL 5ctCARBOXYMETHYLCELLULOSE SODIUMUnited Exchange Corp48879feb-b5ae-a9e6-e063-6394a90a03b22026-01-16WarningsExact identifier
unii: K679OBS311
Family Care Single Use Lubricant Eye Drop 0.4mL 30ctCARBOXYMETHYL CELLULOSE 0.5%United Exchange Corp488b3363-8d06-7dcc-e063-6294a90ab44c2026-01-16WarningsExact identifier
unii: K679OBS311
metformin hydrochlorideMETFORMIN HYDROCHLORIDE TABLETSEPIC PHARMA, LLC356b02d0-d239-4441-bb33-c4c54166fcd72026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.486fec17-ff83-3bab-e063-6394a90a5ef02026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.e3e9b582-fd15-4fe0-a210-398d9149696e2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
unii: 786Z46389E
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb4697319-438e-2ec8-e053-2a95a90abb562026-01-08WarningsExact identifier
unii: K679OBS311
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb478a695-ded0-2e5f-e053-2995a90ac45e2026-01-08WarningsExact identifier
unii: K679OBS311

Reported adverse events (FAERS/openFDA)#

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