FDA.reportPublic FDA data

NDC 14445-412-30 - ACETYLCYSTEINE

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
14445-412
Requested NDC
14445-412-30
Package NDCs from labels
14445-412-30, 14445-412-04
Manufacturer
Indoco Remedies Limited
Effective date
2022-03-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ACETYLCYSTEINE - Indoco Remedies LimitedIndoco Remedies Limited2022-03-01Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14445-412-04ACETYLCYSTEINE4 in 1 CARTONINJECTION44
14445-412-30ACETYLCYSTEINE30 mL in 1 VIALINJECTION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14445-412ACETYLCYSTEINE INJECTION [INDOCO REMEDIES LIMITED ]4Current NDC, Legacy NDC, 2 package rows20220302_6588c28d-0515-4cdf-99d3-c4ad3fd0976c.zip

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 4 of 10 · 185 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AcetylcysteineACETYLCYSTEINESagent Pharmaceuticalsc206c659-16ea-444a-8c60-8a3343400ada2025-10-26Warnings, Adverse reactionsExact identifier
rxcui: 465377
unii: WYQ7N0BPYC
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AcetylcysteineACETYLCYSTEINEONESOURCE SPECIALTY PHARMA LIMITED3b0310d2-4e70-4b94-8d69-cb5999a32b542025-09-12Warnings, Adverse reactionsExact identifier
rxcui: 465377
unii: WYQ7N0BPYC
AcetylcysteineACETYLCYSTEINEHikma Pharmaceuticals USA Inc.277963a0-8ab2-4305-a688-28e47e87c5842025-09-09Warnings, Adverse reactionsExact identifier
rxcui: 465377
unii: WYQ7N0BPYC
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AcetylcysteineACETYLCYSTEINECameron Pharmaceuticals8165ad85-98e7-438f-9567-5cfda88d0ebf2025-08-26Warnings, Adverse reactionsExact identifier
unii: WYQ7N0BPYC
acetylcysteineACETYLCYSTEINEPadagis US LLC9d305722-e74f-4f48-8d2c-0daa991447492025-07-31Warnings, Adverse reactionsExact identifier
rxcui: 465377
unii: WYQ7N0BPYC
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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