FDA.reportPublic FDA data

NDC 67877-218-33 - 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
67877-218
Requested NDC
67877-218-33
Package NDCs from labels
67877-218-01, 67877-218-05, 67877-218-10, 67877-218-33, 67877-218-38
Manufacturer
Ascend Laboratories, LLC | Alkem Laboratories Limited
Effective date
2025-12-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metformin Hydrochloride - Ascend Laboratories, LLC | Alkem Laboratories LimitedAscend Laboratories, LLC | Alkem Laboratories Limited2025-12-18Human Prescription Drug Label
Metformin Hydrochloride - Major PharmaceuticalsMajor Pharmaceuticals2019-01-14HUMAN PRESCRIPTION DRUG LABEL
Metformin Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2018-01-23Human Prescription Drug Label
Metformin Hydrochloride - Cambridge Therapeutics Technologies, LLCCambridge Therapeutics Technologies, LLC2017-06-08HUMAN PRESCRIPTION DRUG LABEL
Metformin Hydrochloride Tablets USPApotheca Inc.2017-01-17HUMAN PRESCRIPTION DRUG LABEL
Metformin Hydrochloride Tablets USPLiberty Pharmaceuticals, Inc.2016-04-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-218-01Metformin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10024
67877-218-05Metformin Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50024
67877-218-10Metformin Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100024
67877-218-33Metformin Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED1024
67877-218-38Metformin Hydrochloride10 in 1 CARTONTABLET, FILM COATED1024

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-218METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ASCEND LABORATORIES, LLC]23Current NDC, Legacy NDC, 5 package rows20231101_0ff1ba75-3c86-4baf-a6b1-1bb883839866.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-218-01EA - Each67877-218ac872f40-5e74-48a9-a2c1-6a1a598e3fe912012-07-24
67877-218-05EA - Each67877-2188cff2141-56f9-4833-94fe-f8edb3336ae512013-02-13
67877-218-10EA - Each67877-218d81510fd-e7f3-424a-98e1-97525436897012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]11
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]11
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]11
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]11
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]11
TALCINACTIVE INGREDIENT7SEV7J4R1UMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]11
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]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 1 of 133 · 2,647 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.d5228e81-9c86-4781-b984-20feaa2ae7792026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MetforminMETFORMIN ER 500 MGREMEDYREPACK INC.05999192-ebc6-4198-bd1e-f46abbfb4f8a2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 860975
unii: 786Z46389E
TheraTearsCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC17a01236-130f-495b-9f8d-92b6a23b2dc52026-09-09WarningsExact identifier
unii: K679OBS311
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECamber Pharmaceuticals, Inc.7cc02a26-5c22-445b-ad8f-3e7570c143d32026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEGranules India Ltd73197cb5-3e23-4ac0-b189-f9bc848bce662026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutionsb6d7edc9-93d6-4480-906d-55c18d0536002026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
unii: 786Z46389E
Pioglitazone Hydrochloride and Metformin HydrochloridePIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEAurobindo Pharma Limited1fa2703e-fb73-44d5-aaa2-b12b1090d42c2026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Pioglitazone HCL and Metformin HCLPIOGLITAZONE HCL AND METFORMIN HCLTorrent Pharmaceuticals Limited237d8fa2-633c-4c29-84d3-f1b413610dc32026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions64f5b140-7ad8-4c07-bbfc-ae4618afa8502026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.bfd6ec0f-8264-4877-aa6d-f347f53bc4262026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.c568d49f-c040-4f1e-ad36-77b05ab659c32026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 860981
unii: 786Z46389E
REFRESH LIQUIGELCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.4b8b2f6a-4b89-446c-9e5b-9b83c453a01d2026-08-28WarningsExact identifier
unii: K679OBS311
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.ba0379cb-824e-4798-9ff9-99bcd1bea5cb2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackfb296500-55cb-45ce-be0c-59aa2e3d46242026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
unii: 786Z46389E
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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