FDA.reportPublic FDA data

NDC 0169-6432-55 - Levemir

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
0169-6432
Requested NDC
0169-6432-55
Package NDCs from labels
0169-6432-55, 0169-6432-10
Manufacturer
A-S Medication Solutions
Effective date
2023-05-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levemir - A-S Medication SolutionsA-S Medication Solutions2023-05-03HUMAN PRESCRIPTION DRUG LABEL
LEVEMIR - A-S Medication SolutionsA-S Medication Solutions2023-03-12HUMAN PRESCRIPTION DRUG LABEL
Levemir - Novo NordiskNovo Nordisk2022-12-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-6432-10Levemir5 in 1 CARTONINJECTION, SOLUTION530
0169-6432-55Levemir3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION330

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-6432LEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]28Legacy NDC, 2 package rows20240605_d38d65c1-25bf-401d-9c7e-a2c3222da8af.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-6432-10ML - Milliliter0169-6432b3b8b05f-c0f2-4aae-8a72-c7ec6c1bcdb912023-01-09
0169-6432-55ML - Milliliter0169-6432919d936a-c88a-4fa3-a14a-788c293b89aa12023-10-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INSULIN DETEMIRACTIVE INGREDIENT4FT78T86XVLEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]15
INSULIN DETEMIRACTIVE MOIETY4FT78T86XVLEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]15
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]15
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]15
METACRESOLINACTIVE INGREDIENTGGO4Y809LOLEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]15
PHENOLINACTIVE INGREDIENT339NCG44TVLEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]15
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]15
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]15
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TLEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]15
ZINCINACTIVE INGREDIENTJ41CSQ7QDSLEVEMIR (INSULIN DETEMIR) INJECTION, SOLUTION [NOVO NORDISK]15

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 55 of 84 · 1,665 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEFresenius Kabi USA, LLC8fce1477-991f-4b43-bf05-a80bad8972622024-10-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMMeijer Distribution Incfb170371-2e5d-43ca-a259-538a973ee3b82024-10-15WarningsExact identifier
unii: PDC6A3C0OX
topcare hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMTopco Associates LLC5e13da07-48cf-40bc-bb11-fd891886cbea2024-10-14WarningsExact identifier
unii: PDC6A3C0OX
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
Carbolicum acidumPHENOLBoiron2439c612-94b8-71c3-e063-6394a90a42c92024-10-11Exact identifier
unii: 339NCG44TV
Carbolicum acidumPHENOLBoiron690ad832-f822-3883-e053-2a91aa0af9692024-10-11Exact identifier
unii: 339NCG44TV
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCc44b0fdb-33df-4747-b443-5fb4deb456cb2024-10-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bacteriostatic Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCe5e325d1-0d58-40c9-9645-3ae402ff9d922024-10-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bliss GVSGLYCERINBliss GVS Pharma Limited1a3982a1-9ce9-4a1a-ba73-ebe2d86471092024-10-10WarningsExact identifier
unii: PDC6A3C0OX
LevemirINSULIN DETEMIRA-S Medication Solutions82192527-99aa-4b53-8ce9-9173668d309c2024-10-09Warnings, Adverse reactionsExact identifier
application number: BLA021536
rxcui: 484322
rxcui: 847239
rxcui: 616238
rxcui: 847241
unii: 4FT78T86XV
Vamousse Lice DefenseEUCALYPTUS GLOBULUS, NATRUM MURIATICUMAlliance Pharma Inc.c87ce5d3-c200-421e-88be-bc8060a5993a2024-10-08WarningsExact identifier
unii: 451W47IQ8X
Energy CatalystVISCUM ALBUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERROUS FUMARATE, MAGNESIUM ASPARTATE, MANGANESE GLUCONATE, PHOSPHORUS, POTASSIUM ASPARTATE, SODIUM MOLYBDATE, ADENOSINUM, CYCLOPHOSPHORICUM, CERIUM OXALICUM, NICKEL ACETATE, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM, CESIUM CHLORIDE, DYSPROSIUM METALLICUM, ERBIUM METALLICUM, ALUMINA,Deseret Biologicals, Inc.99529dd4-f8ab-4348-8b65-dc8c89e1ad542024-10-04WarningsExact identifier
unii: 451W47IQ8X
unii: J41CSQ7QDS
Thyroid HPBARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA IODATA, FUCUS VESICULOSUS, IODIUM, LAPIS ALBUS, LEVOTHYROXINUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SELENIUM METALLICUM, SPONGIA TOSTA, THYROIDINUM (SUIS)Energique, Inc.2f04e425-7160-41a7-aa1e-934db54f17512024-09-30WarningsExact identifier
unii: 451W47IQ8X
Household DetoxPTELEA TRIFOLIATA, ALLIUM SATIVUM, PETROLEUM, CARBONEUM SULPHURATUM, ALUMINA, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PHENACETINUM, SODIUM CARBOXYMETHYL CELLULOSE, FOLLICULINUM, ANTIPYRINUM, DIOXIN, DIETHYLSTILBESTROL, TEFLONDeseret Biologicals, Inc.7e32c1f4-c88e-43d0-9f6c-de736d358d462024-09-27WarningsExact identifier
unii: 339NCG44TV
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, HELIUM, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.cb1566a4-92d4-4f1a-9211-f0c538a83c272024-09-27WarningsExact identifier
unii: 451W47IQ8X
FNGBERBERIS VULGARIS, COCHLEARIA ARMORACIA, ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, MYRRHA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, TABEBUIA IMPETIGINOSA, THYMUS (SUIS), FORMALINUM, CARBOLICUM ACIDUM, FERRUM METALLICUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PULSATILLA (PRASTENSIS), SELENIUM METALLICUM, ZINCUM METALLICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, METHYLCOBALAMIN, SARCOLACTICUM ACIDUM, MUCOR RACEMOSUS, ALTERNARIA TENUIS NEES, ASPERGILLUS NIGER,Deseret Biologicals, Inc.fd32287e-af1a-45d3-b82a-5cc004db6bc92024-09-27WarningsExact identifier
unii: 339NCG44TV
unii: J41CSQ7QDS
Trace Mineral CordALUMINUM, ANTIMONY, BARIUM, BERYLLIUM, BISMUTH, BORON, BROMINE, CALCIUM, CARBON, CERIUM, CESIUM, CHLORIDE, CHROMIUM, COBALT, COPPER, DYSPROSIUM, ERBIUM, EUROPIUM, FLUORIDE, GADOLINIUM, GALLIUM, GERMANIUM, GOLD, HAFNIUM, HOLMIUM, INDIUM, IODINE, IRIDIUM, IRON, LANTHANUM, LITHIUM, LUTETIUM, MAGNESIUM, MANGANESE, MOLYBDENUM, NEODYMIUM, NICKEL, NIOBIUM, OSMIUM, PALLADIUM, PHOSPHORUS, PLATINUM, POTASSIUM, PRASEODYMIUM, RHENIUM, RHODIUM, RUBIDIUM, RUTHENIUM, SAMARIUM, SCANDIUM, SELENIUM, SILICON, SILVEREnergique, Inc.7a34327c-39fe-403b-87a0-4f3bea36bb2a2024-09-27WarningsExact identifier
unii: J41CSQ7QDS
hemorrhoidal maximum strength pain reliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMKroger Company3c8f90e2-fecf-4439-9faa-81a32ffe47532024-09-26WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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