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 12 of 60 · 1,198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Morphine SulfateMORPHINE SULFATEAmerican Health Packaging66a3f607-7f48-490f-84dd-b74dd1ee39e52026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
Morphine SulfateMORPHINE SULFATEHikma Pharmaceuticals USA Inc.ca359246-4674-4b32-b8b2-673d32b7112f2026-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
0.9 percentsalineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd487cb4fc-2e0b-020f-e063-6294a90a45262026-02-03WarningsExact identifier
unii: 451W47IQ8X
0.9salineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd49e76aca-ca2b-3b95-e063-6394a90a875e2026-02-03WarningsExact identifier
unii: 451W47IQ8X
0.9%salineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd49e7b329-e4e5-6991-e063-6294a90ac8172026-02-03WarningsExact identifier
unii: 451W47IQ8X
Morphine SulfateMORPHINE SULFATEHikma Pharmaceuticals USA Inc.3c847554-3b4b-4d24-a145-2ef7e9b836992026-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
Calcium ChlorideCALCIUM CHLORIDEHospira, Inc.c4c65e48-85f8-4dcf-6281-06e40959cc792026-02-02Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Adrenal SupportADRENALINUM, BERBERIS VULGARIS, ARGENTUM NITRICUM, NATRUM MURIATICUM, VANADIUM METALLICUM, OLEUM MORRHUAE, PETROLEUMNaturalCarecee52757-a86e-4251-b65f-954ac85f4e7e2026-01-30WarningsExact identifier
unii: 451W47IQ8X
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SABAL SERRULATA, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.7b15d6fa-eb04-41d2-8a01-6e7408ccf4d32026-01-30WarningsExact identifier
unii: 451W47IQ8X
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
unii: 451W47IQ8X
unii: B22547B95K
CVS ULTRA FINE MOISTURIZING SALINE MISTNASAL MISTCVS44821c47-63f9-5d0a-e063-6394a90a555d2026-01-29WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDENephron Pharmaceuticals Corporationa4edf2d5-a9ff-30d4-e053-2995a90a56502026-01-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack3a89d0ca-4ff8-4bdc-8ea8-9ad591ce72262026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEProPharma Distribution48d73434-e65b-dc98-e063-6294a90affa22026-01-20Adverse reactionsExact identifier
unii: 451W47IQ8X
Equate Comfort Flow Sinus washSINUS WASHWALMART INC9e911eef-ca99-9902-e053-2a95a90aab0e2026-01-19WarningsExact identifier
unii: 451W47IQ8X
EQUATE PREMIUM SALINESODIUM CHLORIDE 0.65%Walmart Stores, Inc.1e17f022-f513-140d-e063-6394a90a379e2026-01-19WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCd98bf9f7-30ec-4927-a577-cabad192cb182026-01-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SWISS BLEU Relief-Calm Antimicrobial Skin CreamLACTOBACILLUS FERMENT LYSATE, LEONTOPODIUM ALPINUM, CALENDULA OFFICINALIS FLOWER EXTRACT, EVENING PRIMROSE FLOWER EXTRACT, CITRIC ACIDNanjing Hongruixing Biological Technology Co., Ltd487d3c2c-ce28-f7a1-e063-6294a90a5ec62026-01-16WarningsExact identifier
unii: 2968PHW8QP
WALGREENS UPSET STOMACH and NAUSEA RELIEFSODIUM CITRATE DIHYDRATEWALGREENS CO.2de7ff66-af75-4d9d-b493-29b37dadc5d82026-01-15WarningsExact identifier
unii: B22547B95K

Reported adverse events (FAERS/openFDA)#

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