FDA.reportPublic FDA data

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 16 of 24 · 471 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MesalamineMESALAMINESun Pharmaceutical Industries Inc.c2f84490-70b8-4998-907d-a77e9f791de12024-08-27Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEBryant Ranch Prepackbaa76dde-3c5b-4ff4-ba0c-f19660a796c12024-08-14Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
MesalamineMESALAMINEPadagis Israel Pharmaceuticals Ltdb2a5b110-7537-4ffc-bf0a-f0fe13379c9d2024-08-01Warnings, Adverse reactionsExact identifier
application number: ANDA076751
ndc (package): 45802-098-46
rxcui: 238151
MesalamineMESALAMINEPadagis Israel Pharmaceuticals Ltdd50f2c37-5675-49f3-bdd4-3b16d333ed402024-08-01Warnings, Adverse reactionsExact identifier
application number: ANDA076751
ndc (package): 45802-098-46
ndc (package): 45802-923-41
ndc (product): 45802-923
rxcui: 238151
spl id: 9e3de2df-02db-474c-9e16-47aeea34b2c5
spl set id: d50f2c37-5675-49f3-bdd4-3b16d333ed40
MesalamineMESALAMINEPadagis Israel Pharmaceuticals Ltda4ddf68d-1502-4242-89aa-c96436bdcbf62024-08-01Warnings, Adverse reactionsExact identifier
application number: ANDA076751
ndc (package): 45802-098-51
ndc (package): 45802-098-46
ndc (product): 45802-098
rxcui: 238151
spl id: f416ded9-2018-4422-8cff-c6fc563a3772
spl set id: a4ddf68d-1502-4242-89aa-c96436bdcbf6
unii: 4Q81I59GXC
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
MesalamineMESALAMINEAscend Laboratories, LLC43f69db3-81ac-4da4-a61f-fbba6299d9c22024-07-03Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINETeva Pharmaceuticals, Inc.e3b84397-a5a5-40cf-8145-0584103d465f2024-06-28Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEBryant Ranch Prepack06792d20-d7e9-4b66-a4cb-cd0cf1a2db252024-06-28Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINERising Pharma Holdings, Inc.de981df1-747a-480d-a866-e72332a1544d2024-06-14Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MESALAMINEMESALAMINEBryant Ranch Prepack063ca661-1b5c-4941-a5b9-5dd0fa46b3d02024-05-29Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEAmneal Pharmaceuticals LLC00f77203-3615-47e8-ae25-6e1cf8a2a00a2024-05-23Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
Sodium Phenylacetate and Sodium BenzoateSODIUM PHENYLACETATE AND SODIUM BENZOATEFOSUN PHARMA USA INCcee1e9a2-bbe5-2419-e053-2a95a90ac3ef2024-05-09Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 6DC9Q167V3
MesalamineMESALAMINEBryant Ranch Prepackc9b1ef9d-1d06-48e7-87d2-7985b99124a62024-05-01Warnings, Adverse reactionsExact identifier
rxcui: 238151
unii: 4Q81I59GXC
mesalamineMESALAMINEGolden State Medical Supply, Inc.170657d1-1f32-f036-e063-6294a90a4ed42024-04-26Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC

Reported adverse events (FAERS/openFDA)#

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