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 71 of 81 · 1,605 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nat MurSODIUM CHLORIDEHyland's Inc.d3ab4254-daaf-24ac-e053-2995a90afb8f2022-12-13WarningsExact identifier
unii: 451W47IQ8X
RestSILVER NITRATE,CAUSTICUM,MATRICARIA CHAMOMILLA,ANAMIRTA COCCULUS SEED,SODIUM CHLORIDE,PHOSPHORUS AND VALERIANHyland's Inc.5e9924be-4dad-324a-e053-2a91aa0a8ec12022-12-13WarningsExact identifier
unii: 451W47IQ8X
Defend Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.bb851be1-0528-4199-91e7-e09f994b28622022-12-12WarningsExact identifier
unii: 451W47IQ8X
BACTERIOSTATIC SODIUM CHLORIDEBACTERIOSTATIC SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst7611e508-6da2-3a2f-e053-2a91aa0a9f402022-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
BACTERIOSTATIC SODIUM CHLORIDEBACTERIOSTATIC SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst763ff805-af1a-e8e9-e053-2a91aa0a82532022-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
f474a2c6-c2fe-4dec-86a9-7fc2aef980f3d38d65c1-25bf-401d-9c7e-a2c3222da8af2022-12-08Warnings, Adverse reactionsExact identifier
spl id: f474a2c6-c2fe-4dec-86a9-7fc2aef980f3
spl set id: d38d65c1-25bf-401d-9c7e-a2c3222da8af
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation2fae04e3-20b1-4b8c-b1fb-646b384836f12022-12-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
MET TOXARSENICUM ALB, AVENA, BERBERIS VULG, LYCOPODIUM, NAT MUR, NUX VOM, PHYTOLACCA, RHAMNUS FRANG, SOLIDAGO, TRIFOLIUM PRATWhite Manufacturing Inc. DBA Micro-West2653d62b-5dd7-482c-b31c-ce5fa13739002022-12-02WarningsExact identifier
unii: 451W47IQ8X
Whole System EepBELLADONNA, BERBER VULG, CAUSTICUM, CEANOTHUS, CHELIDONIUM MAJ, CINCHONA, COFFEA CRUDA, CONDURANGO, GRAPHITES, HYDRASTIS, IGNATIA, LILIUM, LYCOPODIUM, , MERC CORROS, NUX VOM, PANCREAS, SCROPHULARIA NODOSA, SENNA, SPONGIA, ZINC METWhite Manufacturing Inc. DBA Micro-Westccdee0bb-18cc-4180-ac4b-d9dc5c79895e2022-12-02WarningsExact identifier
unii: J41CSQ7QDS
Miranda Castros Healing Gel for Bites and StingsCALENDULA OFFICINALIS, CALADIUM SEGUINUM, LEDUM PALUSTRE, NATRUM MURIATICUM, PLANTAGO MAJOR, STAPHYSAGRIA, URTICA URENS.OHM PHARMA INC.8e06aaa4-c177-45cf-9d8d-e0099de256682022-12-02WarningsExact identifier
unii: 451W47IQ8X
Yonis BlissCHAMOMILLA, NATRUM MURIATICUMBrookhaus Essentials LLCea4091d6-d295-41a0-aae5-68f3c260e1102022-11-30WarningsExact identifier
unii: 451W47IQ8X
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
unii: PDC6A3C0OX
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
unii: PDC6A3C0OX
4 Kids Cold and Mucus NighttimeEUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFURHyland's Inc.6f7b2585-2f0e-5938-e053-2a91aa0aa9d12022-11-21WarningsExact identifier
unii: 451W47IQ8X
4 Kids Complete Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.ef39fe3d-a42d-4baa-9199-91f664feb4322022-11-21WarningsExact identifier
unii: 451W47IQ8X
Multiple Electrolytes pH 7.4SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEFresenius Kabi USA, LLC84221110-b3f1-42f4-800c-ad1d3b330e9e2022-11-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Multiple Electrolytes pH 5.5SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEFresenius Kabi USA, LLCcf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c2022-11-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Natrum MuriaticumNATRUM MURIATICUMHahnemann Laboratories, INC.ecf06f13-012c-212d-e053-2995a90a71982022-11-08Exact identifier
unii: 451W47IQ8X
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC51da05ce-e3c4-4ef5-a845-dc869152e17f2022-10-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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