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 7 of 13 · 253 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MesalamineMESALAMINEZydus Lifesciences Limitedaa63b4bb-2de7-40aa-b26b-1b00b0183eac2025-01-09Exact identifier
unii: 4Q81I59GXC
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MesalamineMESALAMINEZydus Pharmaceuticals USA Inc.f458d574-7b5b-44f1-86be-8b18880dc67f2025-01-08Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
Potassium AcetatePOTASSIUM ACETATEFresenius Kabi USA, LLCbf4dc488-d6f3-41f8-ac8d-37b27f25b8db2024-12-06Warnings, Adverse reactionsExact identifier
unii: M911911U02
Potassium AcetatePOTASSIUM ACETATEFresenius Kabi USA, LLC2f069f41-903a-4a57-b566-eda5c44367d82024-12-06Warnings, Adverse reactionsExact identifier
unii: M911911U02
mesalamineMESALAMINEZydus Lifesciences Limited29c0dd58-d2cf-40fa-bc32-0eab619373312024-11-30Exact identifier
unii: 4Q81I59GXC
mesalamineMESALAMINEZydus Lifesciences Limited52d96501-47f3-45d8-a181-98763b9f89652024-11-30Exact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEZydus Lifesciences Limited04073681-a834-4f45-91c5-224b608b30e62024-11-30Exact identifier
unii: 4Q81I59GXC
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
MesalamineMESALAMINEAmerican Health Packaging77140634-9f32-40ca-8c83-9fcc3e373c162024-11-22Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINENorthStar RxLLC8233f158-9da5-4fd2-b2c3-9db89448371f2024-11-21Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEAmerican Health Packaginga74ab9f4-ffcd-4bbf-88a5-342e6a38aabb2024-11-21Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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