FDA.reportPublic FDA data

NDC 21922-045-01 - 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
21922-045
Requested NDC
21922-045-01
Package NDCs from labels
21922-045-01, 21922-045-47, 21922-045-49
Manufacturer
Encube Ethicals, Inc. | Encube Ethicals Private Limited
Effective date
2025-10-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mesalamine - Encube Ethicals, Inc. | Encube Ethicals Private LimitedEncube Ethicals, Inc. | Encube Ethicals Private Limited2025-10-07HUMAN PRESCRIPTION DRUG LABEL
Mesalamine - Bryant Ranch PrepackBryant Ranch Prepack2024-05-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21922-045-01Mesalamine60 mL in 1 BOTTLE, DISPENSINGSUSPENSION606
21922-045-47Mesalamine7 in 1 CARTONSUSPENSION76
21922-045-49Mesalamine28 in 1 CARTONSUSPENSION286

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-045MESALAMINE SUSPENSION [ENCUBE ETHICALS PRIVATE LIMITED]4Current NDC, 3 package rows20240808_d6b68275-b2a4-4965-9862-cf14acf8c599.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-045-47ML - Milliliter21922-045a3151a33-d466-4e36-a281-5635e7be51f612023-08-08

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 1 of 13 · 256 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
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
RowasaMESALAMINEViatris Specialty LLCe505ab99-1943-4216-a178-4d5dbe64e3b22026-08-03Warnings, Adverse reactionsExact identifier
rxcui: 238151
unii: 4Q81I59GXC
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
mesalamineMESALAMINEMajor Pharmaceuticals14ac4435-903b-41f5-a3c4-8c73de3e4cef2026-07-27Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
mesalamineMESALAMINEZydus Pharmaceuticals USA Inc.ad8c7930-92e2-4372-a874-da22b9ae333e2026-07-14Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
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
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
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
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MesalamineMESALAMINESandoz Inc47b5d1ee-b439-4ccb-9b01-c0875ccd748a2026-06-30Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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