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 20 of 24 · 465 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
unii: HIE492ZZ3T
unii: 33X04XA5AT
AnubisMedSODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREAANUBIS COSMETICS SLebf4b3ab-34e1-185a-e053-2a95a90ace3a2023-09-05WarningsExact identifier
unii: 059QF0KO0R
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: OJ245FE5EU
unii: 1VPU26JZZ4
unii: 8SKN0B0MIM
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: 059QF0KO0R
unii: HIE492ZZ3T
Anubis BarcelonaDMAEANUBIS COSMETICS SLf22b212d-d21d-5984-e053-2995a90a683e2023-09-01WarningsExact identifier
unii: 8SKN0B0MIM
unii: 059QF0KO0R
unii: HIE492ZZ3T
unii: 2KAG279R6R
unii: TTV12P4NEE
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
unii: 059QF0KO0R
unii: TTV12P4NEE
Anubis BarcelonaPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOINANUBIS COSMETICS SLeb9244ea-6102-3cbe-e053-2a95a90ab8f62023-09-01WarningsExact identifier
unii: 14255EXE39
unii: 6DC9Q167V3
unii: 24WE03BX2T
unii: 059QF0KO0R
unii: HIE492ZZ3T
unii: 3QPI1U3FV8
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Anubis Barcelona Vital LineHYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDESANUBIS COSMETICS SLebe024f7-7c45-ad60-e053-2995a90a45d62023-09-01WarningsExact identifier
unii: 8SKN0B0MIM
unii: 059QF0KO0R
unii: HIE492ZZ3T
unii: 2KAG279R6R
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
unii: 8SKN0B0MIM
unii: 059QF0KO0R
unii: 3XUS85K0RA
unii: HIE492ZZ3T
unii: 2KAG279R6R
unii: TTV12P4NEE
Anubis Barcelona Regul OilPROPYLENE GLYCOL, PANTHENOL, THIAMINE HCLANUBIS COSMETICS SLeb8e5beb-4452-58c2-e053-2a95a90a66e02023-09-01WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
unii: A2I8C7HI9T
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
unii: 3XUS85K0RA
unii: HIE492ZZ3T
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
unii: HIE492ZZ3T
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
unii: 8SKN0B0MIM
unii: 059QF0KO0R
unii: HIE492ZZ3T
unii: 2KAG279R6R
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
unii: HIE492ZZ3T
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
unii: 14255EXE39
unii: 6DC9Q167V3
unii: 24WE03BX2T
unii: 059QF0KO0R
unii: HIE492ZZ3T
unii: 3QPI1U3FV8
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
unii: HIE492ZZ3T
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: 8SKN0B0MIM
unii: 059QF0KO0R
unii: HIE492ZZ3T
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 6DC9Q167V3
unii: A1A1I8X02B
unii: 8SKN0B0MIM
unii: 059QF0KO0R
unii: HIE492ZZ3T
unii: 33X04XA5AT
unii: 2KAG279R6R

Reported adverse events (FAERS/openFDA)#

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