FDA.reportPublic FDA data

NDC 0641-6126-01 - 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
0641-6126
Requested NDC
0641-6126-01
Package NDCs from labels
0641-6126-01, 0641-6126-25
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2026-07-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Morphine Sulfate - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2026-07-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6126-01Morphine Sulfate1 mL in 1 VIAL, SINGLE-DOSEINJECTION110
0641-6126-25Morphine Sulfate25 in 1 PACKAGEINJECTION2510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6126MORPHINE SULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 2 package rows20240608_6023606c-150c-40c5-9175-598efe2a56c3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6126-01ML - Milliliter0641-6126616b70c6-2c23-4d62-9594-942de254788812015-10-02
0641-6126-25ML - Milliliter0641-6126744a2924-a5dd-448c-948b-829295ea466f12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPMORPHINE SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMORPHINE SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMORPHINE SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMORPHINE SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMORPHINE SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
WATERINACTIVE INGREDIENT059QF0KO0RMORPHINE SULFATE INJECTION [WEST-WARD PHARMACEUTICALS 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 11 of 59 · 1,164 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LibidotoneARALIA QUINQUEFOLIA, BERBERIS VULGARIS, AGNUS CASTUS, AVENA SATIVA, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, HYPOPHYSIS SUIS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, SEPIAEnergique, Inc.4ceacaa0-0219-421a-8fff-c1784c3d0f702026-02-27WarningsExact identifier
unii: 451W47IQ8X
911 Adrenal Burnout and FatigueACETICUM AC, ADRENALINUM, ADRENOCORTICOTROPHIN (30X), AESCULUS HIPPOCASTANUM, FLOS, ALFALFA, ALPHA-LIPOIC AC, AMBRA, ARG NIT, AVENA SATIVA, BRYONIA, CARBONEUM OXYGENISATUM, CARPINUS BETULUS, FLOS, DNA, FUMARICUM ACIDUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS, KALI PHOSPHORICUM, LACTICUM ACIDUM, LECITHIN, NATRUM MURIATICUM, OXALICUM ACIDUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SEPIA, SILICEA, SUCCINICUM ACIDUM AND THYROIDINUM.King Bio Inc.21c6b6c1-e846-4f25-a1dc-02e79d1be7562026-02-26WarningsExact identifier
unii: 451W47IQ8X
Oimmal Gentle Eye WashSODIUM CHLORIDEShenzhen Shandian Jingling Technology Co., Ltd.4bb4e59b-a43e-fa38-e063-6294a90aea712026-02-26WarningsExact identifier
unii: 451W47IQ8X
sodium chlorideSODIUM CHLORIDEMedefil, Inc.d1468c0f-dd4f-4d38-a84c-c1d1103039652026-02-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ResentmentADRENALINUM, AMMONIUM MURIATICUM, APOCYNUM CANNABINUM, BUTHUS AUSTRALIS, CARDUUS MARIANUS, CINCHONA OFFICINALIS, FEL TAURI, HEPAR SUIS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS SUIS, MANGANUM CARBONICUM, MOSCHUS, NAJA TRIPUDIANS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, RHUS TOX, TARAXACUM OFFICINALEDeseret Biologicals, Inc.f42e08d9-349e-4e53-802c-175cf17f3f2c2026-02-26WarningsExact identifier
unii: 451W47IQ8X
TricitratesTRICITRATESChartwell Governmental & Specialty RX, LLC.c4ff0407-3930-4c48-afd4-d2cb3e1b18f42026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC.fd57a176-7faf-4053-b348-6ba5f192f05a2026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Anti-Itch Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, HYPERICUM PERFORATUM WHOLE, AND SODIUM CHLORIDEForces of Nature6131d921-c772-4684-b9ea-c5c8923daaf02026-02-25WarningsExact identifier
unii: 451W47IQ8X
BM BIO28 (General Tonic)CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited38d2cff0-3550-b119-e063-6394a90a31cb2026-02-23WarningsExact identifier
unii: 451W47IQ8X
Allergy KidsURTICA DIOICA LEAF, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND ALTHAEA OFFICINALIS ROOTForces of Nature4886109c-dd7d-40c0-911f-5f12343d8e632026-02-20WarningsExact identifier
unii: 451W47IQ8X
Allergy Maximum StrengthURTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature122ca23e-43f1-4e5c-afc2-1418b17176792026-02-20WarningsExact identifier
unii: 451W47IQ8X
Back Pain Pain ManagementARNICA MONTANA, HORSE CHESTNUT, HYPERICUM PERFORATUM, RUTA GRAVEOLENS WHOLE, AND SODIUM CHLORIDEForces of Naturebf089347-f334-4d6d-ab58-cf7f0b16810f2026-02-20WarningsExact identifier
unii: 451W47IQ8X
MITIGOMORPHINE SULFATEPiramal Critical Care, Inc.728f3d83-9a63-0c1f-e053-2a91aa0ac7db2026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
Morphine SulfateMORPHINE SULFATECranbury Pharmaceuticals, LLCd8598654-94ad-4cfb-81d2-9b68e013a4282026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
RHODODIUMACTEA RACEMOSA, APIS MELL, CALC CARB, GRAPHITES, IODIUM, NATRUM MUR, PULSATILLA, RHODODENDRONBM Private Limited3b3bcba2-6f9e-cd94-e063-6394a90a77012026-02-15WarningsExact identifier
unii: 451W47IQ8X
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack07993f6c-146b-4728-a2da-6e93089f78ff2026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
Walgreens ULTRA FINE MOISTURIZING SALINE MISTNASAL MISTWALGREEN COMPANY48fef521-1b1d-d0d5-e063-6394a90ac7b12026-02-10WarningsExact identifier
unii: 451W47IQ8X
Walgreens SALINE MISTNASAL MISTWALGREEN COMPANY44815675-cc1d-a582-e063-6394a90ae8f62026-02-10WarningsExact identifier
unii: 451W47IQ8X
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

Reported adverse events (FAERS/openFDA)#

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