FDA.reportPublic FDA data

NDC 0641-6154-01 - Doxercalciferol

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
0641-6154
Requested NDC
0641-6154-01
Package NDCs from labels
0641-6154-01, 0641-6154-25
Manufacturer
Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A
Effective date
2019-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DOXERCALCIFEROL INJECTIONHikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A2019-12-30HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0641-6154-252025-01-30C16284748780-12cef2736-af7b-d83d-e063-dadaa90ab31fDOXERCALCIFEROL INJECTION

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6154DOXERCALCIFEROL INJECTION [HIKMA PHARMACEUTICALS USA INC.]6Legacy NDC20191231_e99a1d29-3989-4437-999e-4e9cab8b9b1e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXERCALCIFEROLACTIVE INGREDIENT3DIZ9LF5Y9DOXERCALCIFEROL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
DOXERCALCIFEROLACTIVE MOIETY3DIZ9LF5Y9DOXERCALCIFEROL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDOXERCALCIFEROL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHDOXERCALCIFEROL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
SODIUM ASCORBATEINACTIVE INGREDIENTS033EH8359DOXERCALCIFEROL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDOXERCALCIFEROL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FDOXERCALCIFEROL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWDOXERCALCIFEROL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
WATERINACTIVE INGREDIENT059QF0KO0RDOXERCALCIFEROL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3

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 50 of 54 · 1,080 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
InterSolPLATELET ADDITIVE 3Fenwal, Inc.e4f06c0b-7cb1-49c9-97a4-2cfc212984952021-11-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
CONSTIPATION CPALUMINUM OXIDE, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, GRAPHITE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SULFUR, SODIUM CHLORIDE, MAGNESIUM CHLORIDE, LEAD, SEPIA OFFICINALIS JUICE.Natural Creations, Inc.961b3ddf-41fe-46ed-b5e4-0fd8d9652edf2021-11-15WarningsExact identifier
unii: 451W47IQ8X
CENTROCODEAMERICAN GINSENG, ADENOSINE TRIPHOSPHATE, CORTICOTROPIN, ALFALFA, BOS TAURUS HYPOTHALAMUS, PHYTOLACCA AMERICANA ROOT, BOS TAURUS PITUITARY GLAND POSTERIOR, THYROID UNSPECIFIED, IODINE, SILICON DIOXIDE, OSTER SHELL CALCIUM CARBONATE CRUDE, STRYCHNOS IGNATII SEED, IRIDIUM, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, SELENIUM, URANYL NITRATE HEXAHYDRATE.Natural Creations, Inc.e5bbe9ec-7602-4de5-907a-7047c10198b62021-11-15WarningsExact identifier
unii: 451W47IQ8X
OHM-ANXARGENTUM NITRICUM, AURUM METALLICUM, AVENA SATIVA, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, IGNATIA AMARA, MOSCHUS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, STANNUM METALLICUM, VALERIANA OFFICINALISOHM PHARMA INC.f743b690-8f79-4e60-81cd-e3e2825a1ec82021-11-15WarningsExact identifier
unii: 451W47IQ8X
Hydrate 2BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUANatural Creations, Inc52cb98dc-6858-42bf-9c54-d20fb607dfbb2021-11-12WarningsExact identifier
unii: 451W47IQ8X
Adrenal and DHEAARALIA QUINQUEFOLIA, ASHWAGANDHA, AVENA SATIVA, CARDUUS MARIANUS, DHEA, GLANDULA SUPRARENALIS SUIS, L-ARGININE, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, RHODIOLA.ProBLEN44991952-c440-4a33-9423-a9369c8bab702021-10-22WarningsExact identifier
unii: 451W47IQ8X
Dr. Talbots Daily Allergy ReliefALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUMTalbot's Pharmaceuticals Family Products, LLC.91c2795d-4cde-6e2c-e053-2995a90a00962021-10-05WarningsExact identifier
unii: 451W47IQ8X
Solucion InterSolSOLUCION ADITIVA PARA PLAQUETAS 3Fenwal, Inc.d5eaf5f4-67d3-4475-af9a-f5b0f882f5d12021-10-04Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
NATRUM MURIATICUMNATRUM MURIATICUMRxhomeo Private Limited d.b.a. Rxhomeo, Inc520edb18-5f2a-4448-ba53-83408a839e1f2021-09-02WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Lactated Ringers IrrigationSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDEB. Braun Medical Inc.0db56c7a-2b8f-4593-8591-2c481c92b2cf2021-08-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium Chloride for IrrigationSODIUM CHLORIDE FOR IRRIGATIONB. Braun Medical Inc.5bd9b176-0402-4a3f-a6b4-c3f393fc092a2021-08-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEFresenius Kabi USA, LLCe6169d3b-39d2-47f9-8d5b-b53ec069a7222021-07-23Warnings, Adverse reactionsExact identifier
unii: 22ADO53M6F
0.9% SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstc755e41b-acba-7234-e053-2995a90aff0f2021-07-17Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Melange combinationCALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEASeroyal USA0a071fbf-0075-4479-e054-00144ff8d46c2021-07-14WarningsExact identifier
unii: 451W47IQ8X
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC4a655cde-283f-4ec8-a3d9-5f539c55c2042021-05-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCed8fd0c1-ac42-4267-877e-ceadf3831c902021-04-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dr. Talbots Vital 12CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA, ZINC GLUCTalbot's Pharmaceuticals Family Products, LLCc10bb804-8169-63da-e053-2a95a90a83062021-04-28WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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