FDA.reportPublic FDA data

NDC 63629-8679-01 - 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
63629-8679
Requested NDC
63629-8679-01
Package NDCs from labels
63629-8679-1, 63629-8679-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-098-46Mesalamine60 mL in 1 BOTTLEENEMA420 mL4 g in 60mL106
63629-8679-1Mesalamine4 in 1 KITKIT4106
63629-8679-1Mesalamine1 in 1 CARTONKIT1106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8679MESALAMINE KIT [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 3 package rows20241109_1e561474-6169-410e-b83d-7e96d375831d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8679-1EA - Each63629-86795f4df694-5746-4af9-bebc-c225beb38ae212023-08-08

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 9 of 24 · 470 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
Anti Nausea LiquidPHOSPHORATED CARBOHYDRATETOPCO ASSOCIATES LLCfd0e8feb-89b5-42ff-806a-55b7473cf5872025-11-10WarningsExact identifier
unii: IY9XDZ35W2
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AS-3AS-3GVS TM INC3dfa3397-fc13-4659-e063-6394a90a5abc2025-11-06WarningsExact identifier
unii: IY9XDZ35W2
CP2DCP2DGVS TM INC3fa2e438-2ff0-a2df-e063-6394a90ac7b52025-11-06WarningsExact identifier
unii: IY9XDZ35W2
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Systane Complete PFPROPYLENE GLYCOL EMULSIONAlcon Laboratories, Inc.798ffdde-1dba-4a3f-a0b6-937f9e958cca2025-11-03WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Anti NauseaDEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACIDRUGBY LABORATORIES8506b4ab-a19e-4b0d-aa98-143bf75a11712025-10-25WarningsExact identifier
unii: IY9XDZ35W2
NORMOSOL-M AND DEXTROSEDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATEICU Medical Inc.aba60c84-94d9-46d0-bdbb-25e0c4e8cc412025-10-24Warnings, Adverse reactionsExact identifier
unii: M911911U02
Advanced Eye Relief Dry Eye RejuvenationGLYCERIN PROPYLENE GLYCOLBausch & Lomb Incorporated027969ee-64e4-4b08-bab7-c4cc8ed22f5f2025-10-23WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: IY9XDZ35W2
Walgreens Ultra LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4533-2061-e063-6394a90a6e732025-10-17WarningsExact identifier
unii: 6DC9Q167V3
Anti NauseaDEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACIDCardinal Healthb2f0e93f-a2e9-4970-bfb8-de30a62478132025-10-14WarningsExact identifier
unii: IY9XDZ35W2
MesalamineMESALAMINEEncube Ethicals, Inc.d6b68275-b2a4-4965-9862-cf14acf8c5992025-10-07Warnings, Adverse reactionsExact identifier
rxcui: 238151
unii: 4Q81I59GXC
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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