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 8 of 13 · 253 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MesalamineMESALAMINEBryant Ranch Prepack1e561474-6169-410e-b83d-7e96d375831d2024-11-07Warnings, Adverse reactionsExact identifier
rxcui: 238151
MesalamineMESALAMINEBryant Ranch Prepack9756d07b-2939-460f-94d3-e338c28cb9932024-11-07Warnings, Adverse reactionsExact identifier
rxcui: 238151
MesalamineMESALAMINEBryant Ranch Prepackb48df65a-a717-479e-9122-8b0f1406c8412024-11-01Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
AddiclenzBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.8a3b75ca-8fec-4318-8a55-8bde0b82637d2024-10-31WarningsExact identifier
unii: OJ245FE5EU
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
SODIUM PHENYLACETATE AND SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEZydus Pharmaceuticals USA Inc.204e84a7-5440-4537-9e40-06eb56c415e92024-09-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Sodium Phenylacetate and sodium benzoateSODIUM PHENYLACETATE AND SODIUM BENZOATENavinta LLCfbc7bfe3-6faa-45a3-befb-9ad7963c05712024-09-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
CanasaMESALAMINEAllergan, Inc.89d91601-152b-4398-bebe-af1c023e99352024-09-08Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINESun Pharmaceutical Industries Inc.c2f84490-70b8-4998-907d-a77e9f791de12024-08-27Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEBryant Ranch Prepackbaa76dde-3c5b-4ff4-ba0c-f19660a796c12024-08-14Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
MesalamineMESALAMINEPadagis Israel Pharmaceuticals Ltdb2a5b110-7537-4ffc-bf0a-f0fe13379c9d2024-08-01Warnings, Adverse reactionsExact identifier
rxcui: 238151
MesalamineMESALAMINEPadagis Israel Pharmaceuticals Ltdd50f2c37-5675-49f3-bdd4-3b16d333ed402024-08-01Warnings, Adverse reactionsExact identifier
rxcui: 238151
MesalamineMESALAMINEPadagis Israel Pharmaceuticals Ltda4ddf68d-1502-4242-89aa-c96436bdcbf62024-08-01Warnings, Adverse reactionsExact identifier
rxcui: 238151
unii: 4Q81I59GXC
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
MesalamineMESALAMINEAscend Laboratories, LLC43f69db3-81ac-4da4-a61f-fbba6299d9c22024-07-03Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINETeva Pharmaceuticals, Inc.e3b84397-a5a5-40cf-8145-0584103d465f2024-06-28Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEBryant Ranch Prepack06792d20-d7e9-4b66-a4cb-cd0cf1a2db252024-06-28Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC

Reported adverse events (FAERS/openFDA)#

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