FDA.reportPublic FDA data

NDC 58914-501-18 - Canasa

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
58914-501
Requested NDC
58914-501-18
Package NDCs from labels
58914-501-56, 58914-501-42, 58914-501-33, 58914-501-18
Manufacturer
Allergan, Inc.
Effective date
2024-09-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Canasa - Allergan, Inc.Allergan, Inc.2024-09-08HUMAN 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
58914-501-33Canasa3 in 1 BOXSUPPOSITORY330
58914-501-42Canasa42 in 1 BOXSUPPOSITORY4230
58914-501-56Canasa30 in 1 BOXSUPPOSITORY3030

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58914-501CANASA (MESALAMINE) SUPPOSITORY [ALLERGAN, INC.]28Current NDC, Legacy NDC, 3 package rows20241211_89d91601-152b-4398-bebe-af1c023e9935.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58914-501-18EA - Each58914-501bfbdf612-4445-4e22-8ce2-c76c6bd8198212012-07-24
58914-501-42EA - Each58914-501c54f480e-a035-4eaf-ae8d-e86b6ebfa02a12012-07-24
58914-501-56EA - Each58914-501ea6c39be-160c-4bec-be41-a42e08be099712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MesalamineACTIVE INGREDIENT4Q81I59GXCCANASA (MESALAMINE) SUPPOSITORY [APTALIS PHARMA US INC]9
MesalamineACTIVE MOIETY4Q81I59GXCCANASA (MESALAMINE) SUPPOSITORY [APTALIS PHARMA US INC]9
fat, hardINACTIVE INGREDIENT8334LX7S21CANASA (MESALAMINE) SUPPOSITORY [APTALIS PHARMA US INC]9
MESALAMINEACTIVE INGREDIENT4Q81I59GXCCANASA (MESALAMINE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]1
MESALAMINEACTIVE MOIETY4Q81I59GXCCANASA (MESALAMINE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]1
FAT, HARDINACTIVE INGREDIENT8334LX7S21CANASA (MESALAMINE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]1

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 1 of 4 · 61 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
APRISOMESALAMINESalix Pharmaceuticals, Inc.7951139c-b271-45a4-b523-34b23800917b2026-08-27Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
RowasaMESALAMINEViatris Specialty LLCe505ab99-1943-4216-a178-4d5dbe64e3b22026-08-03Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
mesalamineMESALAMINEMajor Pharmaceuticals14ac4435-903b-41f5-a3c4-8c73de3e4cef2026-07-27Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
mesalamineMESALAMINEZydus Pharmaceuticals USA Inc.ad8c7930-92e2-4372-a874-da22b9ae333e2026-07-14Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINESandoz Inc47b5d1ee-b439-4ccb-9b01-c0875ccd748a2026-06-30Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINENuvaila Limited875d573f-99a1-426a-8321-4d511690d5032026-06-03Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEANI Pharmaceuticals, Inc.485ed763-976e-4410-a401-7ff762a931b32026-05-20Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MESALAMINEMESALAMINEKLM Laboratories Private Limited54cfed92-5e28-4a4d-a70f-2a60b5b54c122026-04-01Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
LialdaMESALAMINETakeda Pharmaceuticals America, Inc.3098a080-be86-4265-9818-7fc4beab77b72026-03-24Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEGolden State Medical Supply, Inc.4c4ffb68-3ca4-35cd-e063-6294a90ab9292026-03-05Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEActavis Pharma, Inc.73317da3-cba0-4106-9e88-79b0e2f642af2026-02-24Warnings, Adverse reactionsExact identifier
rxcui: 248420
unii: 4Q81I59GXC
MesalamineMESALAMINEAvKARE22f3ee49-ac57-84f5-e063-6394a90aae912026-01-14Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEChartwell RX, LLC9703f92d-1d15-4376-8b2b-51502c2660122025-12-17Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MESALAMINEMESALAMINECamber Pharmaceuticals, Inc.ef471372-8d9f-4d95-9371-44522c69058f2025-12-10Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINERising Pharma Holdings, Inc.c26ae6cb-041b-4cfc-90ca-c4e1cb23458c2025-12-10Warnings, Adverse reactionsExact identifier
rxcui: 248420
unii: 4Q81I59GXC
MesalamineMESALAMINEIngenus Pharmaceuticals, LLC58503afe-b8d4-4710-a194-e3acd64ecf1f2025-12-05Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEUpsher-Smith Laboratories, LLC1e6978d0-01db-477d-a90f-27561777480f2025-12-01Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEEncube Ethicals, Inc.d6b68275-b2a4-4965-9862-cf14acf8c5992025-10-07Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINETeva Pharmaceuticals USA, Inc.6fd0a906-e1b5-4238-a79b-a195510ddc842025-05-30Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEAmerican Health Packaginge638681d-8fca-4bf8-a1fb-8e52357a64da2025-05-21Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC

Reported adverse events (FAERS/openFDA)#

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