FDA.reportPublic FDA data

NDC 68094-754-01 - 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
68094-754
Requested NDC
68094-754-01
Package NDCs from labels
68094-754-01, 68094-754-58
Manufacturer
Precision Dose Inc.
Effective date
2021-03-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Morphine Sulfate - Precision Dose Inc.Precision Dose Inc.2021-03-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-754-01EA - Each68094-7546d96baa8-43b4-4dea-8ba2-c7304569c4b112018-05-09
68094-754-58EA - Each68094-75485668afd-dd03-4d19-9822-3e8f1e56420f12015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Morphine SulfateACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE SOLUTION [PRECISION DOSE INC.]1
MorphineACTIVE MOIETY76I7G6D29CMORPHINE SULFATE SOLUTION [PRECISION DOSE INC.]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPMORPHINE SULFATE SOLUTION [PRECISION DOSE INC.]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KMORPHINE SULFATE SOLUTION [PRECISION DOSE INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXMORPHINE SULFATE SOLUTION [PRECISION DOSE INC.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUMORPHINE SULFATE SOLUTION [PRECISION DOSE INC.]1
sorbitolINACTIVE INGREDIENT506T60A25RMORPHINE SULFATE SOLUTION [PRECISION DOSE INC.]1
waterINACTIVE INGREDIENT059QF0KO0RMORPHINE SULFATE SOLUTION [PRECISION DOSE INC.]1

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 7 of 30 · 592 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Morphine SulfateMORPHINE SULFATECranbury Pharmaceuticals, LLCd8598654-94ad-4cfb-81d2-9b68e013a4282026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack07993f6c-146b-4728-a2da-6e93089f78ff2026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: PDC6A3C0OX
Viva Hydration BoostGLYCERINNomax Inc174193b2-65eb-b5fd-e063-6394a90a9cd02026-02-10WarningsExact identifier
unii: PDC6A3C0OX
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
application number: NDA022195
ndc (product): 0054-0404
unii: X3P646A2J0
Morphine SulfateMORPHINE SULFATEHikma Pharmaceuticals USA Inc.3c847554-3b4b-4d24-a145-2ef7e9b836992026-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
OptaseGLYCERINScope Health Inc376e0289-28e9-e87f-e063-6294a90a3b042026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc10c3e31d-779d-8ff6-e063-6294a90acd392026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc9e96976b-2990-79e0-e053-2995a90a0f292026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incd81c1a4f-87b0-ee8c-e053-2995a90af9e52026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incf452a2c4-c869-7bf5-e053-2995a90ac1a02026-01-30WarningsExact identifier
unii: PDC6A3C0OX
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
Regener-Eyes Ophthalmic Solution LITE XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.47ab9609-4291-30b2-e063-6394a90a421e2026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.48d6dc98-66e8-b499-e063-6394a90ae9352026-01-29WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc86c14327-ffc7-806e-e053-2991aa0aaf922026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution PROFESSIONALGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC49771efa-6682-51d0-e063-6294a90a18a52026-01-28WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution LITEGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC497763ee-dc70-bb48-e063-6294a90afb3d2026-01-28WarningsExact identifier
unii: PDC6A3C0OX
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

Reported adverse events (FAERS/openFDA)#

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