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 73 of 81 · 1,605 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: PDC6A3C0OX
ErogetoneARALIA QUINQUEFOLIA, BERBERIS VULGARIS, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIAEnergique, Inc.1e872ecd-e7a5-463d-9832-47b7046096db2022-06-28WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Cardioplegic SolutionPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEFresenius Kabi, USA, LLCeb360dc4-88d6-4b28-9b61-bc359e16bd222022-05-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Stomach SaverABIES NIG, ANTIMON CRUD, ARG NIT, ARSENICUM ALB, CARBO VEG, CINCHONA, LYCOPODIUM, NAT PHOS, NUX MOSCH, NUX VOM, PODOPH PELT, ROBINIASilver Star Brandse0048c51-74e3-a7ff-e053-2995a90a1d412022-05-27WarningsExact identifier
unii: GR686LBA74
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: J41CSQ7QDS
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.24a08a93-df23-474b-873e-c59ec8855f9f2022-03-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Wild Horse 777 Moisturizing NasalSODIUM CHLORIDEWild Horse 777, Inc.b0b4dadd-11fa-3dbb-e053-2995a90a20972022-03-14WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.cc14fafd-3dcd-4fc8-bdbd-6f355c3757682022-02-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC8b44bfd3-70a4-4b47-bc7b-590f63b8cc752022-02-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ACNE HPCARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINCNatural Creations, Inc.b2368ab6-e233-4473-99fa-86e1fbc2a8792022-02-14WarningsExact identifier
unii: 451W47IQ8X
unii: J41CSQ7QDS
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCf62481fd-fcdb-4be6-ac13-29c590e925c32022-02-10Adverse reactionsExact identifier
unii: 451W47IQ8X
Drink EaseAVENA SATIVA FLOWERING TOP, CAPSICUM, STRYCHNOS NUX-VOMICA SEED, VERATRUM ALBUM ROOT, AND ZINCMiers Laboratories23317bc3-deac-4756-8f99-d08fa32fbbfc2022-02-04WarningsExact identifier
unii: J41CSQ7QDS
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.e44c41ae-c9c8-4dd8-ba6c-cebb585378aa2022-01-31Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile Saline Mist WalgreensSODIUM CHLORIDEWALGREEN COMPANYd6b9d4fc-b758-be32-e053-2995a90a25232022-01-29WarningsExact identifier
unii: 451W47IQ8X
Extra Strenght Saline Mist Rite AidSODIUM CHLORIDERITE AID CORPORATIONd5b30fb2-4052-4a0c-e053-2a95a90aacd52022-01-16WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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