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 2 of 24 · 470 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRENATE RestoreASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENTAvion Pharmaceuticals, LLC1076ba9a-0168-492f-ba9b-99fa021860922026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33X04XA5AT
Arnicare ArthritisARNICA MONTANA, BENZOIC ACID, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, SOLANUM DULCAMARA TOP, POTASSIUM IODIDE, PULSATILLA VULGARIS, RHODODENDRON AUREUM LEAF, TOXICODENDRON PUBESCENS LEAFLaboratoires Boironcb02378b-617d-4268-b565-4136e50009f42026-07-21Exact identifier
unii: 8SKN0B0MIM
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: 6DC9Q167V3
Best Choice Anti Nausea Cherry FlavorDEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACIDBEST CHOICE (VALU MERCHANDISERS COMPANY)bc8b5208-2dbf-4636-8dd8-68c1ab975f572026-07-17WarningsExact identifier
unii: IY9XDZ35W2
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
mesalamineMESALAMINEZydus Pharmaceuticals USA Inc.ad8c7930-92e2-4372-a874-da22b9ae333e2026-07-14Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
Good Neighbor Anti Nausea Cherry FlavorDEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACIDAMERISOURCE BERGEN82488773-3fef-41a0-afa7-e74ea19cd87d2026-07-13WarningsExact identifier
unii: IY9XDZ35W2
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Leukotrap RC SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC4c0dec79-1648-1cfd-e063-6394a90a88cc2026-07-03Exact identifier
unii: IY9XDZ35W2
Leukotrap WB System - CP2DCP2D/AS-3 - ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC44a82ea8-69bf-f061-e063-6394a90af3da2026-07-03Exact identifier
unii: IY9XDZ35W2
Leukotrap WB system - CP2DCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC42ece7e1-1da1-7e5a-e063-6294a90ac8032026-07-03Exact identifier
unii: IY9XDZ35W2
Leukotrap WB System - CP2DCP2D/AS-3 - ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC44a7d200-13cb-c0b0-e063-6294a90aafad2026-07-03Exact identifier
unii: IY9XDZ35W2
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
SKIN TAG REMOVERSALICYLIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.3a5e2105-7125-183c-e063-6394a90ae8792026-07-02WarningsExact identifier
unii: 33X04XA5AT
WART SKIN TAG REMOVERSALICYLIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.3a5b64a3-b19e-8b1a-e063-6294a90a66412026-07-02WarningsExact identifier
unii: 33X04XA5AT
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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