FDA.reportPublic FDA data

NDC 16571-246-16 - 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
16571-246
Requested NDC
16571-246-16
Package NDCs from labels
16571-246-16, 16571-246-72, 16571-246-03
Manufacturer
Rising Pharma Holdings, Inc. | Bliss GVS Pharma Limited
Effective date
2025-12-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mesalamine - Rising Pharma Holdings, Inc. | Bliss GVS Pharma LimitedRising Pharma Holdings, Inc. | Bliss GVS Pharma Limited2025-12-10Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-246-03Mesalamine5 in 1 CARTONSUPPOSITORY52
16571-246-16Mesalamine6 in 1 BLISTER PACKSUPPOSITORY62
16571-246-72Mesalamine12 in 1 CARTONSUPPOSITORY122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-246MESALAMINE SUPPOSITORY [RISING PHARMA HOLDINGS, INC.]1Current NDC, 3 package rows20250418_c26ae6cb-041b-4cfc-90ca-c4e1cb23458c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-246-03EA - Each16571-2467f55890c-6652-464b-8af5-5c414c6d977812025-05-14
16571-246-16EA - Each16571-246240dbdcd-e4a5-4d2b-ab24-d921fc53f64612025-06-13

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
application number: ANDA219028
ndc (package): 16571-246-16
ndc (package): 16571-246-72
ndc (package): 16571-246-03
ndc (product): 16571-246
ndc11 (package): 16571024616
rxcui: 248420
spl id: 92e26463-9c71-456e-b800-351162846b68
spl set id: c26ae6cb-041b-4cfc-90ca-c4e1cb23458c
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.