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 3 of 3 · 59 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MesalamineMESALAMINEBryant Ranch Prepack06792d20-d7e9-4b66-a4cb-cd0cf1a2db252024-06-28Warnings, Adverse reactionsExact identifier
rxcui: 248420
unii: 4Q81I59GXC
MesalamineMESALAMINERising Pharma Holdings, Inc.de981df1-747a-480d-a866-e72332a1544d2024-06-14Warnings, Adverse reactionsExact identifier
rxcui: 248420
unii: 4Q81I59GXC
MESALAMINEMESALAMINEBryant Ranch Prepack063ca661-1b5c-4941-a5b9-5dd0fa46b3d02024-05-29Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEAmneal Pharmaceuticals LLC00f77203-3615-47e8-ae25-6e1cf8a2a00a2024-05-23Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEBryant Ranch Prepackc9b1ef9d-1d06-48e7-87d2-7985b99124a62024-05-01Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
mesalamineMESALAMINEGolden State Medical Supply, Inc.170657d1-1f32-f036-e063-6294a90a4ed42024-04-26Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MESALAMINEMESALAMINELannett Company Inc.29dbe417-15a9-4c4d-846b-81cabda7ac702024-02-29Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINECamber Pharmaceuticals, Inc.efa9d039-ae1f-4cd6-98f2-e87a901dfaeb2024-02-26Warnings, Adverse reactionsExact identifier
rxcui: 248420
unii: 4Q81I59GXC
MesalamineMESALAMINECamber Pharmaceuticals, Inc.04ce2182-2e8c-4598-a269-550cfaddde6c2024-02-15Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEANI Pharmaceuticals, Inc.3cf751f2-a0c9-45d7-8acb-2bc61db0e4ac2024-02-14Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEAurobindo Pharma Limitedd6c0fc76-644e-4301-9672-f432061e3d372024-01-20Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MESALAMINEMESALAMINEAlembic Pharmaceuticals Inc.87d3d62d-2dc3-4e6f-be33-cabbca12e8f72024-01-09Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
mesalamineMESALAMINETeva Pharmaceuticals USA, Inc.8d27a608-3ba1-4799-be38-c00fb08ce3ce2023-12-19Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
Mesalamine RectalMESALAMINEAmring Pharmaceuticals Inc.87de237c-febb-42ca-b2a4-b444396f86402023-12-15Warnings, Adverse reactionsExact identifier
rxcui: 248420
unii: 4Q81I59GXC
MesalamineMESALAMINESun Pharmaceutical Industries, Inc.fd8b02de-7dfa-444d-a1f8-1436b578e0cb2023-12-01Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEMylan Pharmaceuticals Inc.c8b93ea3-0367-4605-b87f-06c3812ff3b72023-11-30Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEZydus Pharmaceuticals USA Inc.cd8493f7-91fd-4c2d-b3d7-c1301825586b2023-10-26Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
mesalamineMESALAMINEZydus Pharmaceuticals USA Inc.533bfaf5-0add-4b49-a4f2-ddea2b83f65d2023-10-26Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MESALAMINEMESALAMINEAlembic Pharmaceuticals Limited4ef59b85-e5a5-479f-a1fe-e1cee4d876702022-11-07Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC

Reported adverse events (FAERS/openFDA)#

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