FDA.reportPublic FDA data

NDC 76045-005-01 - Morphine Sulfate

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
76045-005
Requested NDC
76045-005-01
Package NDCs from labels
76045-005-01, 76045-005-11, 76045-005-02, 76045-005-12
Manufacturer
Fresenius Kabi, USA LLC | Fresenius Kabi USA, LLC
Effective date
2026-08-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Morphine Sulfate - Fresenius Kabi, USA LLC | Fresenius Kabi USA, LLCFresenius Kabi, USA LLC | Fresenius Kabi USA, LLC2026-08-31HUMAN PRESCRIPTION DRUG LABEL
Morphine Sulfate - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2025-09-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76045-005-01Morphine Sulfate1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION17
76045-005-11Morphine Sulfate10 in 1 CARTONINJECTION, SOLUTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76045-005MORPHINE SULFATE (MORPHINE SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]17Current NDC, Legacy NDC20210310_b62ee1ef-db55-417a-a02e-b103890f9c4b.zip
76045-005MORPHINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI, USA LLC]7Current NDC, Legacy NDC, 2 package rows20250412_1f53de80-efc8-4930-b3e3-fba0d026af05.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76045-005-01ML - Milliliter76045-0055c978217-da01-4faa-967c-2d8bbc49ae4212020-05-08
76045-005-10ML - Milliliter76045-0059e55d236-0483-42b1-a9cd-9133d4ab23bd12014-05-02
76045-005-11ML - Milliliter76045-00560795206-cf27-4003-b569-ce714cb0a73a12020-05-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Morphine SulfateACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE INJECTION, SOLUTION [BD RX INC.]5
MorphineACTIVE MOIETY76I7G6D29CMORPHINE SULFATE INJECTION, SOLUTION [BD RX INC.]5
Calcium ChlorideINACTIVE INGREDIENTM4I0D6VV5MMORPHINE SULFATE INJECTION, SOLUTION [BD RX INC.]5
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPMORPHINE SULFATE INJECTION, SOLUTION [BD RX INC.]5
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KMORPHINE SULFATE INJECTION, SOLUTION [BD RX INC.]5
Sodium chlorideINACTIVE INGREDIENT451W47IQ8XMORPHINE SULFATE INJECTION, SOLUTION [BD RX INC.]5
Trisodium Citrate DihydrateINACTIVE INGREDIENTB22547B95KMORPHINE SULFATE INJECTION, SOLUTION [BD RX INC.]5
WaterINACTIVE INGREDIENT059QF0KO0RMORPHINE SULFATE INJECTION, SOLUTION [BD RX INC.]5

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 41 of 60 · 1,198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph/Spleen ComboJUNIPERUS COMMUNIS, QUERCUS GLANDIUM SPIRITUS, MYOSOTIS ARVENSIS, NATRUM SULPHURICUM, CEANOTHUS AMERICANUS, HELIANTHUS ANNUUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), SPLEEN (SUIS), THYMUS (SUIS), CHININUM ARSENICOSUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, UBIDECARENONUM, FERRUM METALLICUM, SUCCINUM, CASTANEA VESCA, APIS MELLIFICADeseret Biologicals, Inc.b55787b5-5e35-4342-8f00-ef202c3538772024-07-31WarningsExact identifier
unii: 451W47IQ8X
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.4080fcfb-7ef2-45f5-8c3b-592d3b66a1202024-07-29WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporationf55bd888-5e01-474d-871b-24654c0701782024-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC83994d0c-8484-4505-abb5-8a384ed122882024-07-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
sodium chlorideSODIUM CHLORIDEBecton Dickinson and Company8df7dcf6-8714-6caf-e053-2995a90ab8cc2024-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack7f65fa22-c3fc-4413-8a07-2c6be621b7bf2024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
Sodium ChlorideSODIUM CHLORIDECODAN US CORPORATIONaa06e286-75c6-4d7a-959f-6008d38aa6e52024-06-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Derma Pain PlusCROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOXICODENDRON, SARSAPARILLA (SMILAX REGELII)Peaceful Mountain, Inc.6fa79c31-e48e-4c83-baa2-96cef22cfee12024-06-13WarningsExact identifier
unii: 451W47IQ8X
Cold Sore RescueBORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEAPeaceful Mountain, Inc.a7fe6ec7-a758-43cf-b46f-c327e0632fb82024-06-13WarningsExact identifier
unii: 451W47IQ8X
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
NATRUM MURNATRUM MURRxhomeo Private Limited d.b.a. Rxhomeo, Inc1a22655a-68f3-4f13-e063-6294a90ae52c2024-06-05WarningsExact identifier
unii: 451W47IQ8X
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepackfd98b881-5466-457b-b5af-f102aec615462024-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell RX, LLC525136c9-7758-437b-b57b-94b9057868252024-05-31Adverse reactionsExact identifier
unii: 2968PHW8QP
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Mentox HPAURUM METALLICUM, BARYTA CARBONICA, CALCAREA CARBONICA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.ebb23637-4931-4563-ab30-99bea02765802024-05-28WarningsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Lactated Ringers and DextrosePOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLCdbed53b7-0109-4561-8342-0178ec8c64b02024-05-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLC1b912c7e-f005-4af4-b683-0834409642492024-05-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC239a5af1-7498-480f-862c-ab7c3d89d1832024-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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