FDA.reportPublic FDA data

NDC 76045-008-01 - 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
76045-008
Requested NDC
76045-008-01
Package NDCs from labels
76045-008-01, 76045-008-11, 76045-008-00, 76045-008-10
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
76045-008-01Morphine Sulfate1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION17
76045-008-11Morphine Sulfate10 in 1 CARTONINJECTION, SOLUTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76045-008MORPHINE SULFATE (MORPHINE SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]17Current NDC, Legacy NDC20210310_b62ee1ef-db55-417a-a02e-b103890f9c4b.zip
76045-008MORPHINE 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
76045-008-10ML - Milliliter76045-0081a6160d0-a1a9-4a01-a50d-6f650a232b1812014-05-02

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 48 of 58 · 1,145 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlutenstatALFALFA, ZINGIBER OFFICINALE, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, BARLEY (GRAIN), CARBO VEGETABILIS, GLYPHOSATE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, OAT (GRAIN), PULSATILLA (VULGARIS), RYE (GRAIN), WHEAT (GRAIN), GLUTENEnergique, Inc.c6b867b6-74d9-4725-90d7-7d5d1fe611212023-04-05WarningsExact identifier
unii: 451W47IQ8X
AnxietyBORAX, NATRUM MURIATICUM, CAUSTICUM, ELETTARIA CARDAMOMUM, PLUMBUM METALLICUM, SEPIA, LILIUM TIGRINUM, OXYTROPIS LAMBERTIINutritional Specialties, Inc.657ed32f-3ac7-4806-96b4-4c7aa0f65e7f2023-04-03WarningsExact identifier
unii: 451W47IQ8X
Virility LiquescenceAVENA SATIVA, DAMIANA, BERBERIS VULGARIS, EPIMEDIUM GRANDIFLORUM, GLYCERINUM, SABAL SERRULATA, IODIUM, LECITHIN, FERRUM MURIATICUM, NATRUM MURIATICUM, AGNUS CASTUS, BUFO RANA, CINCHONA OFFICINALIS, HUMAN GROWTH HORMONE (HGH), ORCHITINUM (BOVINE), PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, ZINCUM VALERIANICUM, OOPHORINUM (SUIS), SEPIANutritional Specialties, Inc.81cc3e2b-f95e-4ba4-a15f-c07b4def0e2f2023-03-29WarningsExact identifier
unii: 451W47IQ8X
Spleen Thymus LiquescenceCINCHONA OFFICINALIS, QUERCUS GLANDIUM SPIRITUS, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), THYMUS (BOVINE), CHININUM ARSENICOSUM, NATRUM MURIATICUM, HELIANTHUS ANNUUSNutritional Specialties, Inc.bc1cc31e-0e8a-49a2-9654-f00eaa72fc042023-03-24WarningsExact identifier
unii: 451W47IQ8X
Emetrol Chewables Mixed BerrySODIUM CITRATE DIHYDRATEWellSpring Pharmaceutical Corporation4965fab0-828d-4f1d-8d43-a636e0a8c1ea2023-03-23WarningsExact identifier
unii: B22547B95K
Emetrol Chewables OrangeSODIUM CITRATE DIHYDRATEWellSpring Pharmaceutical Corporatione9072f9d-d74c-4e43-bcfe-ee005577df352023-03-23WarningsExact identifier
unii: B22547B95K
Morphine SulfateMORPHINE SULFATEBryant Ranch Prepackb7b86b6d-9a39-494c-bf65-f62e4cdc58072023-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
Insulin Diluting Medium for NovoLogWATER INJECTIONNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Natrum muriaticumSODIUM CHLORIDEBoiron1ef4a040-7bee-11e6-8371-424c583030312023-02-20Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8645e304-a71b-5cba-e053-2a91aa0a2d882023-02-20Exact identifier
unii: 451W47IQ8X
EyeClear ProCALC CARB, CALC FLUOR, CAUSTICUM, CINERARIA, EUPHRASIA, NAPHTHALINUM, NAT MUR, PHOS, QUASSIA, SILICEASilver Star Brandsf4d4943b-cb78-aa71-e053-2a95a90ac6382023-02-16WarningsExact identifier
unii: 451W47IQ8X
triCitrasolTRISODIUM CITRATE DIHYDRATECitra Labs LLC64e7652c-1437-43bd-8ea2-3cafab447b8c2023-02-14Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Anticoagulant Citrate Dextrose AANHYDROUS CITRIC ACID, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATECitra Labs LLC5bcd261e-ebba-4ecb-af22-e5aaeb04499b2023-02-14Warnings, Adverse reactionsExact identifier
unii: B22547B95K
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTESPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESNovel Laboratories, Inc.29d821ff-389c-41fb-8a27-89bd3f022b822023-02-08Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86463b98-58f5-7f65-e053-2a91aa0ad3a22023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8645f130-6a19-ae73-e053-2991aa0ab05b2023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8645eb60-65d1-9d6c-e053-2991aa0a94ef2023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8644ffef-f0e6-5c06-e053-2a91aa0ae83d2023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86466614-b8ee-2335-e053-2a91aa0aa67c2023-01-23Exact identifier
unii: 451W47IQ8X
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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