NDC 69238-2126-01 - 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
69238-2126
Requested NDC
69238-2126-01
Package NDCs from labels
69238-2126-3, 69238-2126-9, 69238-2126-1, 69238-2126-5, 69238-2126-01
Manufacturer
Amneal Pharmaceuticals LLC
Effective date
2026-07-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metformin Hydrochloride - Amneal Pharmaceuticals LLCAmneal Pharmaceuticals LLC2026-07-01HUMAN PRESCRIPTION DRUG LABEL
Metformin Hydrochloride - AvKAREAvKARE2026-05-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-2126-1Metformin Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
69238-2126-3Metformin Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE305
69238-2126-5Metformin Hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE5005
69238-2126-9Metformin Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2126METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS NY LLC]4Current NDC, Legacy NDC, 4 package rows20231128_dc65065b-cba0-46d7-8fb5-3368f3210b4d.zip

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 27 · 534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEQPharma Inc53bde438-4277-f418-e063-6394a90a5ea22026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMylan Pharmaceuticals Inc.4f70f907-08d5-4c2e-a4be-32c6124faa7b2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLProficient Rx LPd2c927eb-12bf-4c7d-9ef5-0036b2dd8c292026-06-01Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.d1d7204a-7e8a-4f76-bf9f-3e798c2632ba2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 860981
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEWestminster Pharmaceuticals, LLC836f3647-bfef-40d1-b475-c0d240241a672026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack1e7ab8da-4ece-499c-b0fb-34e37d991c1c2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEGolden State Medical Supply, Inc.1cb2b2be-595c-4e72-8d2c-c1edc7f856822026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLNorthwind Health Company, LLC13b1e35f-d047-8ddc-e063-6394a90a24dd2026-05-14Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
51b59b71-5da1-dbb2-e063-6394a90ab15fdb893bbe-95af-bbec-e053-2a95a90ae0e92026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 51b59b71-5da1-dbb2-e063-6394a90ab15f
spl set id: db893bbe-95af-bbec-e053-2a95a90ae0e9
Metformin hydrochlorideMETFORMIN HYDROCHLORIDEUNICHEM PHARMACEUTICALS (USA), INC.93c8deae-3103-4cbf-a5d1-fe0d37e76df82026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 860975
rxcui: 860981
unii: 786Z46389E
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.a58ff524-e975-4d51-a896-e869f8ea66242026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackbe023bca-511e-4801-bd2b-e30dd14087722026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.c284c146-436b-4eea-9dca-d7d21c82778c2026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECoupler LLC51285096-e2ce-0f3c-e063-6394a90a35d42026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MetforminMETFORMINREMEDYREPACK INC.27f603ec-25e6-4270-a7a3-34a64a76f7ef2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MetforminMETFORMIN ER 500 MGGranules Pharmaceuticals Inc.6d6ee6f8-9650-ff4f-e053-2991aa0acf192026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 860975
rxcui: 860981
unii: 786Z46389E
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E
MetforminMETFORMINIngenus Pharmaceuticals, LLC49a0b5c2-ebaf-4c4c-905f-dfd1962ac6472026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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