NDC 43598-976-11 - DEXMEDETOMIDINE HYDROCHLORIDE

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
43598-976
Requested NDC
43598-976-11
Package NDCs from labels
43598-976-11, 43598-976-58
Manufacturer
Dr.Reddy's Laboratories Inc | GLAND PHARMA LIMITED
Effective date
2022-07-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dexmedetomidine - Dr.Reddy's Laboratories Inc | GLAND PHARMA LIMITEDDr.Reddy's Laboratories Inc | GLAND PHARMA LIMITED2022-07-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-976-11DEXMEDETOMIDINE HYDROCHLORIDE50 mL in 1 VIALINJECTION, SOLUTION503
43598-976-58DEXMEDETOMIDINE HYDROCHLORIDE10 in 1 CARTONINJECTION, SOLUTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-976DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [DR.REDDY'S LABORATORIES INC]3Current NDC, Legacy NDC, 2 package rows20240627_d174c19d-56f1-4ef4-087c-23c26db8e40b.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 51 of 51 · 1,001 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporationf09f80bf-2f8b-4420-865d-aec2d5e5cd4d2012-06-12Exact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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