FDA.reportPublic FDA data

NDC 0472-1915-01 - 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
0472-1915
Requested NDC
0472-1915-01
Package NDCs from labels
0472-1915-01, 0472-1915-30
Manufacturer
Actavis Pharma, Inc.
Effective date
2026-02-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mesalamine - Actavis Pharma, Inc.Actavis Pharma, Inc.2026-02-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0472-1915-01Mesalamine1 in 1 POUCHSUPPOSITORY19
0472-1915-30Mesalamine30 in 1 BOXSUPPOSITORY309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-1915MESALAMINE SUPPOSITORY [ACTAVIS PHARMA, INC.]7Current NDC, Legacy NDC, 2 package rows20231218_73317da3-cba0-4106-9e88-79b0e2f642af.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-1915-01EA - Each0472-19158993fc09-1fba-4d33-840d-faf73a81192d12021-05-05
0472-1915-30EA - Each0472-1915f951b91e-b4bf-4b31-8999-baecff5a736012021-05-05

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 3 · 59 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
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
application number: ANDA205654
ndc (package): 0472-1915-01
ndc (package): 0472-1915-30
ndc (product): 0472-1915
ndc11 (package): 00472191501
rxcui: 248420
spl id: 380df1f0-2282-4c49-bd7c-40b244f875d4
spl set id: 73317da3-cba0-4106-9e88-79b0e2f642af
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
MesalamineMESALAMINEActavis Pharma, Inc.ba1e3bd4-fbe0-46a5-961e-167ccb09672c2025-03-27Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC

Reported adverse events (FAERS/openFDA)#

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