NDC 45802-923-49 - Mesalamine

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
45802-923
Requested NDC
45802-923-49
Package NDCs from labels
45802-923-41, 45802-923-49
Manufacturer
Bryant Ranch Prepack
Effective date
2024-11-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mesalamine - Bryant Ranch PrepackBryant Ranch Prepack2024-11-07HUMAN PRESCRIPTION DRUG LABEL
Mesalamine - Padagis Israel Pharmaceuticals LtdPadagis Israel Pharmaceuticals Ltd2024-08-01HUMAN PRESCRIPTION DRUG LABEL
Mesalamine - Perrigo New York IncPerrigo New York Inc2019-08-15HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-098-46Mesalamine60 mL in 1 BOTTLEENEMA420 mL4 g in 60mL14
45802-923-41Mesalamine1 in 1 CARTONKIT114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-923MESALAMINE KIT [PADAGIS ISRAEL PHARMACEUTICALS LTD]14Current NDC, Legacy NDC, 2 package rows20241017_d50f2c37-5675-49f3-bdd4-3b16d333ed40.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-923-41EA - Each45802-923ff56bce9-918f-4737-9443-505a0c3cc29212012-07-24
45802-923-49EA - Each45802-923730d663e-9f62-4882-a01f-5031f344fdba12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MESALAMINEACTIVE INGREDIENT4Q81I59GXCMESALAMINE KIT [PERRIGO NEW YORK INC]3
MESALAMINEACTIVE MOIETY4Q81I59GXCMESALAMINE KIT [PERRIGO NEW YORK INC]3
CARBOMER HOMOPOLYMER TYPE BINACTIVE INGREDIENTHHT01ZNK31MESALAMINE KIT [PERRIGO NEW YORK INC]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMESALAMINE KIT [PERRIGO NEW YORK INC]3
POTASSIUM ACETATEINACTIVE INGREDIENTM911911U02MESALAMINE KIT [PERRIGO NEW YORK INC]3
POTASSIUM METABISULFITEINACTIVE INGREDIENT65OE787Q7WMESALAMINE KIT [PERRIGO NEW YORK INC]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMESALAMINE KIT [PERRIGO NEW YORK INC]3
WATERINACTIVE INGREDIENT059QF0KO0RMESALAMINE KIT [PERRIGO NEW YORK INC]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEMESALAMINE KIT [PERRIGO NEW YORK INC]3
MESALAMINEACTIVE INGREDIENT4Q81I59GXCMESALAMINE KIT [PERRIGO NEW YORK INC]2
MESALAMINEACTIVE MOIETY4Q81I59GXCMESALAMINE KIT [PERRIGO NEW YORK INC]2
CARBOMER HOMOPOLYMER TYPE BINACTIVE INGREDIENTHHT01ZNK31MESALAMINE KIT [PERRIGO NEW YORK INC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMESALAMINE KIT [PERRIGO NEW YORK INC]2
POTASSIUM ACETATEINACTIVE INGREDIENTM911911U02MESALAMINE KIT [PERRIGO NEW YORK INC]2
POTASSIUM METABISULFITEINACTIVE INGREDIENT65OE787Q7WMESALAMINE KIT [PERRIGO NEW YORK INC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMESALAMINE KIT [PERRIGO NEW YORK INC]2
WATERINACTIVE INGREDIENT059QF0KO0RMESALAMINE KIT [PERRIGO NEW YORK INC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEMESALAMINE KIT [PERRIGO NEW YORK INC]2

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 22 of 24 · 465 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MESALAMINEMESALAMINEAlembic Pharmaceuticals Limited4ef59b85-e5a5-479f-a1fe-e1cee4d876702022-11-07Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Kali AceticumKALI ACETICUMHahnemann Laboratories, INC.e3b7552d-2aaa-9d5b-e053-2a95a90ab6f62022-07-13Exact identifier
unii: M911911U02
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: OJ245FE5EU
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Acidum BenzoicumACIDUM BENZOICUMHahnemann Laboratories, INC.dca1f84c-443f-61ba-e053-2995a90a618a2022-04-14Exact identifier
unii: 8SKN0B0MIM
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: 7FLD91C86K
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: 7FLD91C86K
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
OHM Fatigue ReliefACETICUM AC, ADRENAL GLAND, ARNICA, BENZOICUM AC, FERRUM PHOS, FLUORICUM AC, GINSENG, KALI CARB, KALI LOD, KALI MUR, KALI PHOS, LACTICUM AC, PHOSPHORICUM AC, PICRICUM AC.OHM PHARMA INC.419c6315-37de-46b4-8bef-abbeace265b62021-12-29WarningsExact identifier
unii: 8SKN0B0MIM
Benzoicum AcidumBENZOICUM ACIDUMOHM PHARMA INC.93945281-8cd5-44fd-9772-8f291fa1780f2021-12-29WarningsExact identifier
unii: 8SKN0B0MIM
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Vitamin B ComplexTHIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDEMylan Institutional LLC282ccec8-9bcd-4571-9b91-bbb96ef2620d2021-09-15Warnings, Adverse reactionsExact identifier
unii: 1O6C93RI7Z
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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